| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P170030
S060 |
30-Day Notice | Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System |
Biotronik, Inc. | 02/22/2026 |
|
P030011
S097 |
Real-Time Process | SynCardia Total Artificial Heart (STAH) System |
Syncardia Systems, LLC | 02/20/2026 |
|
P050006
S117 |
30-Day Notice | GORE® CARDIOFORM ASD Occluder; GORE® CARDIOFORM Septal Occluder |
W.L. Gore & Associates, Inc. |
02/20/2026 |
|
P060001
S055 |
30-Day Notice | Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System |
Medtronic Vascular, Inc. | 02/20/2026 |
|
P100018
S052 |
Real-Time Process | PIPELINE EMBOLIZATION DEVICE | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
02/20/2026 |
|
P100026
S103 |
30-Day Notice | NeuroPace® RNS® System | NeuroPace, Inc. | 02/20/2026 |
|
P110023
S064 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent With Entrust™ Delivery Syste |
Medtronic Vascular, Inc. | 02/20/2026 |
|
P110042
S203 |
Normal 180 Day Track | EMBLEM S-ICD Electrode (Lead) | Boston Scientific Corporation |
02/20/2026 |
|
P120017
S039 |
30-Day Notice | Myocardial Pacing Lead | Medtronic, Inc. | 02/20/2026 |
|
P170030
S059 |
30-Day Notice | Orsiro Mission Sirolimus Eluting Coronary Stent System, Synsiro Pro Sirolimus Eluting Coronary Stent System |
Biotronik, Inc. | 02/20/2026 |
|
P200039
S019 |
Normal 180 Day Track | Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat |
Shockwave Medical, Inc. | 02/20/2026 |
|
P240012
S005 |
Normal 180 Day Track No User Fee |
AeroPace® System | Lungpacer Medical USA, Inc. |
02/20/2026 |
|
P240029
S001 |
30-Day Notice | CGuard™ Prime Carotid Stent System | Inspiremd, Ltd. | 02/20/2026 |
| P250023 | Original | Allurion™ Gastric Balloon System | Allurion Technologies, Inc. |
02/20/2026 |
|
P910073
S185 |
Normal 180 Day Track No User Fee |
ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ Pace/sense Defibrillation Leads |
Boston Scientific | 02/20/2026 |
|
P020016
S013 |
30-Day Notice | Total Temporomandibular Joint Replacement System |
Biomet Microfixation, Inc. |
02/19/2026 |
|
P030054
S435 |
135 Review Track For 30-Day Notice |
Quartet; QuickFlex Micro | Abbott Medical | 02/19/2026 |
|
P150035
S026 |
135 Review Track For 30-Day Notice |
Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular) |
Abbott Medical | 02/19/2026 |
|
P180003
S014 |
30-Day Notice | BioMimics 3D® Vascular Stent System | Veryan Medical, Ltd. | 02/19/2026 |
|
P190015
S029 |
30-Day Notice | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 02/19/2026 |
|
P190018
S047 |
Real-Time Process | Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic |
Alcon Laboratories, LLC | 02/19/2026 |
|
P200045
S022 |
30-Day Notice | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 02/19/2026 |
|
P250019
S001 |
Normal 180 Day Track No User Fee |
SAPIEN M3 Transcatheter Mitral Valve Replacement System |
Edwards Lifesciences, LLC |
02/19/2026 |
|
P840001
S615 |
Real-Time Process | Master Restore, Itrel, Synerg, Intellis, Vanta And Inceptiv Spinal Cord Stimulation Systems And Pisces, Specify, And Vec |
Medtronic Neuromodulation |
02/19/2026 |
|
P950022
S148 |
135 Review Track For 30-Day Notice |
Durata, Optisure | Abbott Medical | 02/19/2026 |
|
P960013
S129 |
135 Review Track For 30-Day Notice |
Tendril STS; OptiSense; UltiPace | Abbott Medical | 02/19/2026 |
|
P960030
S080 |
135 Review Track For 30-Day Notice |
IsoFlex | Abbott Medical | 02/19/2026 |
|
P030052
S030 |
30-Day Notice | UroVysion Bladder Cancer Kit | Abbott Molecular | 02/18/2026 |
|
P060040
S121 |
Real-Time Process | HeartMate II Left Ventricular Assist System (LVAS) |
Abbott Medical | 02/18/2026 |
|
P100047
S234 |
Normal 180 Day Track | HeartWare® HVAD System | Medtronic | 02/18/2026 |
|
P110012
S023 |
30-Day Notice | Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. | 02/18/2026 |
|
P130005
S049 |
30-Day Notice | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM |
Cardiovascular Systems, Inc. |
02/18/2026 |
|
P150041
S008 |
30-Day Notice | Vysis CLL FISH Probe Kit | Abbott Molecular, Inc. | 02/18/2026 |
|
P160054
S115 |
Real-Time Process | HeartMate 3™ Left Ventricular Assist System (LVAS) |
Abbott Medical | 02/18/2026 |
|
P170038
S028 |
30-Day Notice | CentriMag Circulatory Support System | Abbott | 02/18/2026 |
|
P190015
S027 |
Real-Time Process | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | 02/18/2026 |
|
P230044
S003 |
30-Day Notice | Alfapump System | Sequana Medical NV | 02/18/2026 |
|
P240039
S002 |
135 Review Track For 30-Day Notice |
SetPoint System | SetPoint Medical | 02/18/2026 |
|
P240044
S002 |
Real-Time Process | Globe Catheter (601-01000) | Kardium, Inc. | 02/18/2026 |
|
P180035
S034 |
30-Day Notice | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 02/17/2026 |
|
P220030
S010 |
30-Day Notice | UNIPURE C3F8 Ophthalmic Gas In The UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas In The UNIPEXY Gas Delivery |
Alcon Research, LLC | 02/17/2026 |
|
P230012
S010 |
30-Day Notice | UNIPURE SF6 Ophthalmic Gas In The UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas In The UNIPEXY Gas Delivery Sy |
Alcon Research, LLC | 02/17/2026 |
|
P230017
S009 |
Normal 180 Day Track | PulseSelect™ Pulsed Field Ablation (PFA) System |
Medtronic, Inc. | 02/17/2026 |
|
P230040
S027 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 02/17/2026 |
|
P000058
S096 |
Panel Track | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. |
02/13/2026 |
|
P010012
S602 |
30-Day Notice | ACUITY™ X4 Straight/ Model 4671; ACUITY X4 Straight/ Model 4672; ACUITY X4 Spiral S/ Model 4674; ACUITY X4 Spiral S/ Mod |
Boston Scientific Corp | 02/13/2026 |
|
P030054
S441 |
30-Day Notice | Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); |
Abbott Medical | 02/13/2026 |
|
P110019
S140 |
30-Day Notice | XIENCE Alpine Everolimus Eluting Coronary Stent System; XIENCE Sierra Everolimus Eluting Coronary Stent System; XIENCE P |
Abbott Vascular | 02/13/2026 |
|
P110042
S208 |
30-Day Notice | EMBLEM™ S-ICD/ Model 3501 | Boston Scientific Corporation |
02/13/2026 |
|
P140002
S033 |
30-Day Notice | MISAGO® RX Self-expanding Peripheral Stent |
Terumo Medical Corporation |
02/13/2026 |
|
P140010
S101 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic, Inc. | 02/13/2026 |
|
P150012
S179 |
30-Day Notice | INGEVITY™ MRI/ Model 7731; INGEVITY™ MRI/ Model 7732; INGEVITY™ MRI/ Model 7735; INGEVITY™ MRI/ Model 7736; INGEVITY™ MR |
Boston Scientific | 02/13/2026 |
|
P190008
S046 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular, Inc. | 02/13/2026 |
|
P230040
S026 |
Special (Immediate Track) |
Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 02/13/2026 |
|
P830055
S358 |
30-Day Notice | LCS® Total Knee System | Depuy, Inc. | 02/13/2026 |
|
P830055
S361 |
30-Day Notice | LCS® Total Knee System | Depuy, Inc. | 02/13/2026 |
|
P840001
S609 |
135 Review Track For 30-Day Notice |
Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™, And V |
Medtronic Neuromodulation |
02/13/2026 |
|
P910023
S483 |
30-Day Notice | Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); |
Abbott Medical | 02/13/2026 |
|
P910073
S186 |
30-Day Notice | RELIANCE 4-FRONT™/model 0636; RELIANCE 4-FRONT/ Model 0662; RELIANCE 4-FRONT/ Model 0663 00802526592805 P910073; RELIANC |
Boston Scientific | 02/13/2026 |
|
P920015
S303 |
30-Day Notice | Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M) |
Medtronic, Inc. | 02/13/2026 |
|
P010015
S580 |
30-Day Notice | Consulta CRT-P C4TR01 Syncra CRT-P C2TR01 |
Medtronic, Inc. | 02/12/2026 |
|
P010031
S916 |
30-Day Notice | Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D |
Medtronic Cardiac Rhythm Disease Management |
02/12/2026 |
|
P020024
S072 |
30-Day Notice | Amplatzer™ Piccolo™ Occluder | Abbott Medical | 02/12/2026 |
|
P080025
S339 |
30-Day Notice | SNS Bowel Neurostimulator Models 97800, 97810; SNS Bowel Screening Trialing System Model 3531 |
Medtronic Neuromodulation |
02/12/2026 |
|
P120008
S031 |
30-Day Notice | ARCHITECT AFP; Alinity I AFP (LN 3P36/07P90) |
Abbott Laboratories | 02/12/2026 |
|
P130013
S083 |
30-Day Notice | WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Delivery System |
Boston Scientific Corp | 02/12/2026 |
|
P130021
S179 |
135 Review Track For 30-Day Notice |
Evolut PRO, PRO+, FX, FX+ | Medtronic, Inc. | 02/12/2026 |
|
P140013
S018 |
30-Day Notice | Minerva Endometrial Ablation System | Axora Medical, Inc. | 02/12/2026 |
|
P140017
S033 |
135 Review Track For 30-Day Notice |
Melody Transcatheter Pulmonary Valve | Medtronic, Inc. | 02/12/2026 |
|
P140031
S199 |
30-Day Notice | Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) |
Edwards Lifesciences, LLC |
02/12/2026 |
|
P160037
S026 |
30-Day Notice | BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay |
Becton, Dickinson and Company |
02/12/2026 |
|
P170006
S040 |
135 Review Track For 30-Day Notice |
Avalus Bioprostheses | Medtronic, Inc. | 02/12/2026 |
|
P190009
S012 |
30-Day Notice | OPRA Implant System | Integrum AB | 02/12/2026 |
|
P200015
S073 |
30-Day Notice | Edwards Commander Delivery System (9600LDS20, 9600LDS23 9600LDS26, 9600LDS29) |
Edwards Lifesciences, LLC |
02/12/2026 |
|
P200046
S045 |
135 Review Track For 30-Day Notice |
Harmony Transcatheter Pulmonary Valve |
Medtronic, Inc. | 02/12/2026 |
|
P200049
S015 |
30-Day Notice | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Abbott Medical | 02/12/2026 |
|
P220012
S067 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 02/12/2026 |
| P220031 | Original | LimiFlex Dynamic Sagittal Tether | Empirical Spine, Inc. | 02/12/2026 |
|
P230013
S023 |
30-Day Notice | Edwards EVOQUE Tricuspid Valve Replacement System (9850TDS) |
Edwards Lifesciences, LLC |
02/12/2026 |
|
P230021
S003 |
Normal 180 Day Track No User Fee |
Duo Venous Stent System | Philips Image Guided Therapy Corporation |
02/12/2026 |
|
P240006
S014 |
Normal 180 Day Track No User Fee |
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; Ngen™ Pump) |
Biosense Webster, Inc. | 02/12/2026 |
|
P240011
S006 |
30-Day Notice | Altaviva Model P7850N | Medtronic Neuromodulation |
02/12/2026 |
|
P250003
S004 |
Special (Immediate Track) |
Embrace™ Hydrogel Embolic System (HES) |
Instylla, Inc. | 02/12/2026 |
|
P830055
S357 |
Special (Immediate Track) |
LCS® Total Knee System | Depuy, Inc. | 02/12/2026 |
|
P840001
S617 |
30-Day Notice | External Neurostimulator (ENS) Model 97725; Intellis Model 97716; Intellis™ Model 97715; SCS Implantable Neurostimulator |
Medtronic Neuromodulation |
02/12/2026 |
|
P860004
S456 |
30-Day Notice | Drug Delivery Infusion Pump Model 8667 |
Medtronic, Inc. | 02/12/2026 |
|
P910007
S067 |
30-Day Notice | ARCHITECT Total PSA; Alinity I Total PSA (LN 6C06/07P92) |
Abbott Laboratories | 02/12/2026 |
|
P950037
S280 |
Normal 180 Day Track | Solia CSP S 53; Solia CSP S 60 | Biotronik, Inc. | 02/12/2026 |
|
P960009
S528 |
30-Day Notice | DBS Implantable Neurostimulator Models B35200, B35300; DBS Implantable Neurostimulators Activa Family Models 37601, 3760 |
Medtronic, Inc. | 02/12/2026 |
|
P970004
S444 |
30-Day Notice | SNS Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531 |
Medtronic Neuromodulation |
02/12/2026 |
|
P970031
S078 |
135 Review Track For 30-Day Notice |
Freestyle Bioprosthesis | Medtronic, Inc. | 02/12/2026 |
|
P980007
S056 |
30-Day Notice | ARCHITECT Free PSA; Alinity I Free PSA (LN 6C07/07P93) |
Abbott Laboratories | 02/12/2026 |
|
P980016
S949 |
30-Day Notice | Evera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD |
Medtronic Cardiac Rhythm Disease Management |
02/12/2026 |
|
P980035
S832 |
30-Day Notice | Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 |
Medtronic, Inc. | 02/12/2026 |
|
P980043
S086 |
135 Review Track For 30-Day Notice |
Hancock II Bioprosthesis | Medtronic, Inc. | 02/12/2026 |
|
P990064
S096 |
135 Review Track For 30-Day Notice |
Mosaic Bioprosthesis | Medtronic, Inc. | 02/12/2026 |
|
P000009
S125 |
30-Day Notice | PHYLAX AV ICD SYSTEM | Biotronik, Inc. | 02/11/2026 |
|
P010031
S914 |
30-Day Notice | Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt |
Medtronic Cardiac Rhythm Disease Management |
02/11/2026 |
|
P010032
S245 |
Real-Time Process | 8-channel Adapter, M, 10cm; 8-channel Adapter, M, 60cm; 8-channel Adapter, B, 10cm; 8-channel Adapter, B, 60cm; Legacy M |
Abbott Medical | 02/11/2026 |
|
P030017
S387 |
135 Review Track For 30-Day Notice |
Precision Spinal Cord Stimulator (SCS) Systems Introducer Hub Mold Change |
Boston Scientific Corp | 02/11/2026 |
|
P050023
S205 |
30-Day Notice | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD |
Biotronik, Inc. | 02/11/2026 |
|
P060001
S056 |
30-Day Notice | Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System |
Medtronic Vascular, Inc. | 02/11/2026 |
|
P080025
S332 |
135 Review Track For 30-Day Notice |
InterStim® Therapy System, Verify® Evaluation System |
Medtronic Neuromodulation |
02/11/2026 |
|
P110023
S065 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent With Entrust™ Delivery Syste |
Medtronic Vascular, Inc. | 02/11/2026 |
|
P130018
S006 |
30-Day Notice | ProACT Adjustable Continence Therapy For Men |
Uromedica, Inc. | 02/11/2026 |
|
P130021
S181 |
30-Day Notice | EnVeo PRO Delivery Catheter System (ENVPRO-16-US), Evolut PRO+ Delivery Catheter System (D-EVPROP2329US, D-EVPROP34US), |
Medtronic, Inc. | 02/11/2026 |
|
P140009
S126 |
Real-Time Process | 8CH Infinity™ DBS Lead Kit, 30cm, 0.5, B; 8CH Infinity™ DBS Lead Kit, 30cm, 1.5, B; 8CH Infinity™ DBS Lead Kit, 40cm, 0 |
Abbott Medical | 02/11/2026 |
|
P150013
S032 |
Panel Track | PD-L1 IHC 22C3 Pharmdx | Agilent Technologies, Inc. |
02/11/2026 |
|
P150033
S221 |
30-Day Notice | Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac |
Medtronic, Inc. | 02/11/2026 |
|
P160054
S118 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 02/11/2026 |
|
P200046
S046 |
30-Day Notice | Harmony™ Delivery Catheter System (HARMONY-DCS) |
Medtronic, Inc. | 02/11/2026 |
|
P220012
S065 |
30-Day Notice | Aurora EV ICD | Medtronic, Inc. | 02/11/2026 |
|
P230013
S022 |
30-Day Notice | Edwards EVOQUE Loading System (9850LSA); Edwards EVOQUE Loading System And Trimmer (9850LSB) |
Edwards Lifesciences, LLC |
02/11/2026 |
|
P230035
S006 |
Normal 180 Day Track No User Fee |
AGENT Paclitaxel-Coated Balloon Catheter |
Boston Scientific Corporation |
02/11/2026 |
|
P240003
S007 |
30-Day Notice | Minima Stent System | Renata Medical, Inc. | 02/11/2026 |
| P250034 | Original | Optune Pax | Novocure, GmbH | 02/11/2026 |
|
P840001
S608 |
135 Review Track For 30-Day Notice |
Restore, Itrel®, Synergy®, IntellisTM And VantaTM Spinal Cord Stimulation Systems And PiscesTM, Specify®, And Vectris® S |
Medtronic Neuromodulation |
02/11/2026 |
|
P930014
S160 |
30-Day Notice | AcrySof® Posterior Chamber Intraocular Lens And Delivery Systems |
Alcon Laboratories, Inc. | 02/11/2026 |
|
P950037
S283 |
30-Day Notice | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS |
Biotronik, Inc. | 02/11/2026 |
|
P960009
S520 |
135 Review Track For 30-Day Notice |
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
Medtronic, Inc. | 02/11/2026 |
|
P960043
S130 |
30-Day Notice | Perclose ProGuide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure And Repair System |
Abbott Vascular, Inc. | 02/11/2026 |
|
P970004
S437 |
135 Review Track For 30-Day Notice |
InterStim® Therapy System, Verify® Evaluation System |
Medtronic Neuromodulation |
02/11/2026 |
|
P980016
S947 |
30-Day Notice | Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; Mirro |
Medtronic Cardiac Rhythm Disease Management |
02/11/2026 |
|
P980023
S142 |
30-Day Notice | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM |
Biotronik, Inc. | 02/11/2026 |
|
P990004
S078 |
30-Day Notice | SURGIFOAM® Absorbable Gelatin Sponge |
Ferrosan Meidcal Devices A/S |
02/11/2026 |
|
P010015
S578 |
30-Day Notice | Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T |
Medtronic, Inc. | 02/10/2026 |
|
P010015
S579 |
30-Day Notice | Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua |
Medtronic, Inc. | 02/10/2026 |
|
P010031
S915 |
30-Day Notice | Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt |
Medtronic Cardiac Rhythm Disease Management |
02/10/2026 |
|
P010032
S247 |
30-Day Notice | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Abbott Medical | 02/10/2026 |
|
P030036
S156 |
30-Day Notice | SelectSecure Lead | Medtronic Cardiac Rhythm Disease Management |
02/10/2026 |
|
P060039
S119 |
30-Day Notice | Attain StarFix Lead | Medtronic, Inc. | 02/10/2026 |
|
P080011
S196 |
30-Day Notice | Biofinity Sphere And Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses For Extended Wear |
CooperVision, Inc. | 02/10/2026 |
|
P130021
S183 |
30-Day Notice | Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni |
Medtronic, Inc. | 02/10/2026 |
|
P140009
S128 |
30-Day Notice | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
Abbott Medical | 02/10/2026 |
|
P150013
S033 |
Panel Track | PD-L1 IHC 22C3 Pharmdx | Agilent Technologies, Inc. |
02/10/2026 |
|
P150033
S220 |
30-Day Notice | Micra AV2 TPS; Micra VR2 TPS | Medtronic, Inc. | 02/10/2026 |
|
P200029
S011 |
Panel Track | TheraSphere | Boston Scientific Corporation |
02/10/2026 |
|
P200046
S049 |
30-Day Notice | Harmony™ Transcatheter Pulmonary Valve |
Medtronic, Inc. | 02/10/2026 |
|
P220012
S066 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 02/10/2026 |
|
P220030
S008 |
Real-Time Process | UNIPURE C3F8 Ophthalmic Gas In The UNIFEYE Gas Delivery System |
Alcon Research, LLC | 02/10/2026 |
|
P230012
S008 |
Real-Time Process | UNIPURE SF6 Ophthalmic Gas In The UNIFEYE Gas Delivery System |
Alcon Research, LLC | 02/10/2026 |
| P240045 | Original | Optimum Infinite (tisilfocon A) Orthokeratology Lenses II |
Contamac, Ltd. | 02/10/2026 |
|
P830061
S233 |
30-Day Notice | CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen |
Medtronic Cardiac Rhythm Disease Management |
02/10/2026 |
|
P840064
S089 |
Normal 180 Day Track | VISCOAT™ Ophthalmic Viscosurgical Device |
Alcon Laboratories | 02/10/2026 |
|
P850089
S173 |
30-Day Notice | CapSure SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB |
Medtronic Cardiac Rhythm Disease Management |
02/10/2026 |
|
P890003
S484 |
30-Day Notice | CapSure VDD-2 Lead 5038, 5038L, 5038S Service Kit-Pacemaker Repair Kit 5873C Vitatron Brilliant S+ VDD Lead IMW14Q, IMW1 |
Medtronic, Inc. | 02/10/2026 |
|
P920015
S302 |
30-Day Notice | HV Splitter/Adaptor Kit 5019 IS-1 Connector Port Pin Plug Kit 6725 Sprint Quattro Lead 6935, 6947 Sprint Quattro Lead 69 |
Medtronic, Inc. | 02/10/2026 |
|
P930039
S275 |
30-Day Notice | CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall |
Medtronic, Inc. | 02/10/2026 |
|
P950024
S116 |
30-Day Notice | CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968) |
Medtronic, Inc. | 02/10/2026 |
|
P960043
S129 |
30-Day Notice | Perclose™ ProGlide Suture-Mediated Closure System; Perclose™ ProStyle Suture-Mediated Closure And Repair System |
Abbott Vascular, Inc. | 02/10/2026 |
|
P980016
S948 |
30-Day Notice | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I |
Medtronic Cardiac Rhythm Disease Management |
02/10/2026 |
|
P980035
S829 |
30-Day Notice | Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01); Astra S DR MRI IPG (X3DR01); Astra S SR |
Medtronic, Inc. | 02/10/2026 |
|
P980035
S831 |
30-Day Notice | Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDR06, ADDRL1, ADSR03, ADVDD01, SED01, SES01, VEDR01); Adapta, Versa, Sensia |
Medtronic, Inc. | 02/10/2026 |
|
P110023
S063 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent With Entrust™ Delivery Syste |
Medtronic Vascular, Inc. | 02/09/2026 |
|
P230043
S004 |
30-Day Notice | Cologuard Plus™ | Exact Sciences Corporation |
02/09/2026 |
|
P170011
S061 |
Real-Time Process | Impella RP System, Impella RP With Smart Assist System, Impella RP Flex System |
Abiomed, Inc. | 02/06/2026 |
|
P240011
S007 |
30-Day Notice | Altaviva™ Tibial Neuromodulation System (Altaviva™ P7850N) |
Medtronic Neuromodulation |
02/06/2026 |
|
P840001
S618 |
30-Day Notice | Master Restore™, Itrel™, Synergy Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™, |
Medtronic Neuromodulation |
02/06/2026 |
|
P860004
S457 |
30-Day Notice | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (Drug Delivery Infusion Pump 8667) |
Medtronic, Inc. | 02/06/2026 |
|
P130008
S124 |
Normal 180 Day Track | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | 02/06/2026 |
|
P140003
S135 |
Real-Time Process | Impella 2.5 System; Impella CP System; Impella CP With Smart Assist System; Impella 5.0 System, Impella 5.5 With Smart A |
Abiomed, Inc. | 02/06/2026 |
|
P150048
S096 |
Normal 180 Day Track No User Fee |
TRIFORMIS RESILIA Tricuspid Valve, Model 11300T |
Edwards Lifesciences, LLC |
02/06/2026 |
|
P150048
S097 |
Normal 180 Day Track No User Fee |
TRIFORMIS RESILIA Tricuspid Valve, Model 11300T |
Edwards Lifesciences, LLC |
02/06/2026 |
|
P910001
S124 |
135 Review Track For 30-Day Notice |
ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 02/06/2026 |
|
P960009
S529 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS, DBS Neurostimulator Implantable, DBS Neuros |
Medtronic, Inc. | 02/06/2026 |
|
P040024
S147 |
30-Day Notice | Restylane Lyft With Lidocaine | Q-Med AB | 02/05/2026 |
|
P110019
S139 |
30-Day Notice | XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra Everolimus Eluting Coronary Stent |
Abbott Vascular | 02/05/2026 |
|
P120020
S035 |
30-Day Notice | Supera Peripheral Stent System | Abbott Vascular (Idef Technologies Inc) |
02/05/2026 |
|
P160021
S050 |
30-Day Notice | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis |
W.L. Gore & Associates, Inc. |
02/05/2026 |
|
P170022
S007 |
Normal 180 Day Track | PyloPlus UBT System | Arj Medical, Inc. | 02/05/2026 |
|
P060028
S060 |
30-Day Notice | MENTOR™ MemoryShape™ Breast Implants |
Mentor Worldwide, LLC | 02/04/2026 |
|
P170006
S042 |
30-Day Notice | Avalus™ Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus™ Ultra Bioprosthesis Model 400 (400U1 |
Medtronic, Inc. | 02/04/2026 |
|
P990075
S067 |
30-Day Notice | MENTOR™ Saline-Filled And SPECTRUM™ Breast Implants |
Mentor Worldwide, LLC | 02/04/2026 |
|
P030053
S087 |
30-Day Notice | MENTOR™ MemoryGel™ Breast Implants |
Mentor Corp. | 02/04/2026 |
|
P130021
S180 |
30-Day Notice | Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron |
Medtronic, Inc. | 02/04/2026 |
|
P160054
S117 |
30-Day Notice | HeartMate 3 Left Ventricular Assist System |
Abbott Medical | 02/04/2026 |
|
P170008
S061 |
30-Day Notice | EluNIR™ Ridaforolimus Eluting Coronary Stent System |
Medinol , Ltd. | 02/04/2026 |
|
P230009
S013 |
30-Day Notice | Shield | Guardant Health, Inc. | 02/04/2026 |
|
P250003
S003 |
30-Day Notice | Embrace™ Hydrogel Embolic System | Instylla, Inc. | 02/04/2026 |
|
P000009
S126 |
30-Day Notice | PHYLAX AV ICD SYSTEM | Biotronik, Inc. | 02/03/2026 |
|
P050023
S206 |
30-Day Notice | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD |
Biotronik, Inc. | 02/03/2026 |
|
P070008
S174 |
30-Day Notice | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD |
Biotronik, Inc. | 02/03/2026 |
|
P100042
S038 |
Panel Track | APTIMA HPV ASSAY | Gen-Probe Incorporated | 02/03/2026 |
|
P100047
S236 |
30-Day Notice | HeartWare® HVAD System | Medtronic | 02/03/2026 |
|
P110019
S138 |
30-Day Notice | XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine), XIENCE Sierra Everolimus Eluting Coronary Stent |
Abbott Vascular | 02/03/2026 |
|
P120007
S034 |
Normal 180 Day Track | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 02/03/2026 |
|
P140031
S189 |
Normal 180 Day Track No User Fee |
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve |
Edwards Lifesciences, LLC |
02/03/2026 |
|
P170038
S027 |
30-Day Notice | CentriMag Circulatory Support System | Abbott | 02/03/2026 |
|
P220013
S027 |
30-Day Notice | TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T |
Abbott Medical | 02/03/2026 |
|
P950037
S284 |
30-Day Notice | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS |
Biotronik, Inc. | 02/03/2026 |
|
P980023
S143 |
30-Day Notice | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM |
Biotronik, Inc. | 02/03/2026 |
|
P080011
S195 |
30-Day Notice | Biofmity XR Torie (comfilcon A) Soft (Hydrophilic) Contact Lenses For Extended Wear |
CooperVision, Inc. | 02/02/2026 |
|
P160029
S029 |
30-Day Notice | HeartStart OnSite Defibrillator (Model M5066A) And HeartStart Home Defibrillator (Model M5068A) |
Philips Medical Systems, Inc. |
02/02/2026 |
|
P180028
S018 |
30-Day Notice | HeartStart FRx Defibrillator | Philips Medical Systems | 02/02/2026 |
|
P230013
S021 |
30-Day Notice | Edwards EVOQUE Tricuspid Valve Replacement System |
Edwards Lifesciences, LLC |
02/02/2026 |
| P250009 | Original | SQUID Liquid Embolic Agent (LEA) | Balt USA, LLC | 01/30/2026 |
|
P190008
S038 |
135 Review Track For 30-Day Notice |
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
Medtronic Vascular, Inc. | 01/30/2026 |
|
P130008
S133 |
30-Day Notice | QMR Battery Separator Supplier | Inspire Medical Systems | 01/30/2026 |
|
P140010
S091 |
135 Review Track For 30-Day Notice |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter And IN.PACT 018 Paclitax |
Medtronic, Inc. | 01/30/2026 |
|
P180011
S060 |
Normal 180 Day Track No User Fee |
Eluvia Drug-Eluting Vascular Stent System |
Boston Scientific Corp | 01/30/2026 |
