| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P010032
S242 |
30-Day Notice | Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Abbott Medical | 08/29/2025 |
|
P040043
S144 |
30-Day Notice | GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System (CMDS) 00733132646890; 00733132646906; 007331326 |
W. L. GORE & ASSOCIATES, INC. |
08/29/2025 |
|
P140009
S123 |
30-Day Notice | Infinity™ Deep Brain Stimulation (DBS) IPG |
Abbott Medical | 08/29/2025 |
|
P150004
S089 |
30-Day Notice | Proclaim™ Doral Root Ganglion (DRG) IPG |
Abbott Medical | 08/29/2025 |
|
P160017
S124 |
Panel Track | MiniMed 780G System | MEDTRONIC MINIMED, INC. | 08/29/2025 |
|
P200030
S022 |
30-Day Notice | GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941; 00733132650958; 00 |
W. L. Gore and Associates, Inc. |
08/29/2025 |
|
P230036
S014 |
30-Day Notice | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Abbott Medical | 08/29/2025 |
|
P240013
S015 |
30-Day Notice | Sphere-9 Catheter Mapping And Ablation Catheter |
Medtronic Inc. | 08/29/2025 |
|
P830055
S348 |
30-Day Notice | LCS Total Knee System | DEPUY, INC. | 08/29/2025 |
|
P860004
S448 |
Special (Immediate Track) |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
MEDTRONIC Inc. | 08/29/2025 |
|
P080025
S328 |
30-Day Notice | InterStim™ Therapy System; Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
08/28/2025 |
|
P160015
S020 |
Normal 180 Day Track No User Fee |
AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS |
ZOLL MEDICAL CORPORATION | 08/28/2025 |
|
P160022
S042 |
Normal 180 Day Track No User Fee |
AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS |
ZOLL MEDICAL CORPORATION | 08/28/2025 |
|
P180038
S027 |
30-Day Notice | LIAISON® Murex Anti-HBc And LIAISON® MUREX Control Anti-hbc |
DiaSorin Inc. | 08/28/2025 |
|
P180047
S040 |
30-Day Notice | LIAISON® QuantiFERON® - TB Gold Plus And LIAISON® Control QuantiFERON-TBGold Plus |
DiaSorin, Inc. | 08/28/2025 |
|
P190017
S028 |
30-Day Notice | LIAISON® XL MUREX HBsAg Qual And LIAISON® XL MUREX Control HBsAg Qual |
DiaSorin Inc | 08/28/2025 |
|
P200035
S028 |
Special (Immediate Track) |
OrganOx Metra® System | OrganOx Limited | 08/28/2025 |
|
P840001
S604 |
30-Day Notice | Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces-Quad™, Spe |
MEDTRONIC NEUROMODULATION |
08/28/2025 |
|
P860004
S447 |
30-Day Notice | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters |
MEDTRONIC Inc. | 08/28/2025 |
|
P960009
S516 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 08/28/2025 |
|
P970004
S433 |
30-Day Notice | InterStim™ Therapy System; Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
08/28/2025 |
|
BP170122
1054 |
Normal 180 Day Track | ReCell Autologous Cell Harvesting Device |
Avita Medical | 08/28/2025 |
|
P030054
S436 |
Real-Time Process | Quartet™ 1456Q, 1457Q, 1458Q, 1458QL; Avant™ HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant™ HF CDHFA500B, CDHFA |
Abbott Medical | 08/27/2025 |
|
P040047
S078 |
Special (Immediate Track) |
COAPTITE Injectable Implant | MERZ NORTH AMERICA, INC | 08/27/2025 |
|
P130021
S174 |
Panel Track | Evolut PRO+ System, Evolut FX System, Evolut FX+ System |
Medtronic, Inc. | 08/27/2025 |
|
P160008
S028 |
Real-Time Process | HeartSine Technologies LLC's Samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P And SAM 450P) |
HeartSine Technologies, Ltd. |
08/27/2025 |
|
P160054
S110 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 08/27/2025 |
| P240044 | Original | Globe® Pulsed Field System | Kardium Inc. | 08/27/2025 |
|
P910023
S479 |
Real-Time Process | Avant™ DR CDDRA700Q, CDDRA700T; Gallant™ DR CDDRA500Q, CDDRA500T; Entrant™ DR CDDRA300Q, CDDRA300T; Neutrino™ NxT DR CDD |
Abbott Medical | 08/27/2025 |
|
P950039
S041 |
30-Day Notice | ThinPrep Processor And ThinPrep Imaging System |
HOLOGIC, INC. | 08/27/2025 |
|
P960030
S081 |
Real-Time Process | IsoFlex™ (1944) | Abbott Medical | 08/27/2025 |
|
P160054
S111 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 08/26/2025 |
|
P230040
S018 |
30-Day Notice | CorPASS System | Endotronix, Inc. | 08/26/2025 |
|
P040020
S115 |
30-Day Notice | AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s |
Alcon Research, Ltd. | 08/25/2025 |
|
P040038
S049 |
30-Day Notice | XACT Carotid Stent System | ABBOTT VASCULAR INC. | 08/25/2025 |
|
P160007
S053 |
30-Day Notice | Guardian Connect System | MEDTRONIC MINIMED | 08/25/2025 |
|
P160017
S126 |
30-Day Notice | MiniMed 670G System | MEDTRONIC MINIMED, INC. | 08/25/2025 |
|
P160037
S022 |
Normal 180 Day Track No User Fee |
BD ONCLARITY HPV ASSAY | BECTON, DICKINSON AND COMPANY |
08/25/2025 |
|
P190018
S043 |
30-Day Notice | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, |
Alcon Laboratories, LLC | 08/25/2025 |
|
P210032
S022 |
30-Day Notice | TAG® Thoracic Branch Endoprosthesis (P210032) |
W. L. Gore & Associates, Inc. |
08/25/2025 |
|
P220014
S008 |
Normal 180 Day Track | CraniSeal Dural Sealant | Pramand, LLC | 08/25/2025 |
|
P250012
S001 |
30-Day Notice | Simplera Sync Sensor, Guardian 4 Sensor |
Medtronic MiniMed Inc. | 08/25/2025 |
|
P930014
S157 |
30-Day Notice | AcrySof® Posterior Chamber Intraocular Lens And Delivery Systems |
ALCON LABORATORIES, INC. | 08/25/2025 |
|
P050023
S197 |
Real-Time Process | CardioMessenger Smart 4G | BIOTRONIK, INC. | 08/22/2025 |
|
P150012
S153 |
135 Review Track For 30-Day Notice |
INGEVITY™ MRI, INGEVITY™ + | BOSTONSCIENTIFIC | 08/22/2025 |
|
P200035
S026 |
Normal 180 Day Track | OrganOx Metra System | OrganOx Limited | 08/22/2025 |
|
P240009
S004 |
Special (Immediate Track) |
Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System With Integrated Embolic Protection |
Contego Medical Inc. | 08/22/2025 |
|
P910073
S176 |
135 Review Track For 30-Day Notice |
ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™ |
BOSTON SCIENTIFIC | 08/22/2025 |
|
P960004
S106 |
135 Review Track For 30-Day Notice |
FINELINE® II EZ Sterox | BOSTON SCIENTIFIC | 08/22/2025 |
|
P990040
S036 |
30-Day Notice | TRUFILL N-bca Liquid Embolic System | Cerenovus, Inc. | 08/22/2025 |
|
P030039
S031 |
30-Day Notice | Coseal Spray Set | BAXTER BIO SCIENCE | 08/21/2025 |
|
P140017
S031 |
30-Day Notice | Melody Transcatheter Pumonary Valve System |
MEDTRONIC Inc. | 08/21/2025 |
|
P150033
S215 |
30-Day Notice | Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) |
MEDTRONIC Inc. | 08/21/2025 |
|
P150040
S021 |
30-Day Notice | Visumax; VISUMAX 800 | Carl Zeiss Meditec, Inc. | 08/21/2025 |
|
P170038
S026 |
30-Day Notice | CentriMag™ Circulatory Support System |
Abbott | 08/21/2025 |
|
P180038
S026 |
30-Day Notice | LIAISON® MUREX Anti-HBc And LIAISON® MUREX Control Anti-HBc |
DiaSorin Inc. | 08/21/2025 |
|
P180047
S038 |
30-Day Notice | LIAISON® QuantiFERON® - TB Gold Plus And LIAISON® XL Control QuantiFERON-TB Gold Plus |
DiaSorin, Inc. | 08/21/2025 |
|
P190002
S041 |
Real-Time Process | Saluda Medical Evoke SCS System | SALUDA MEDICAL PTY LTD | 08/21/2025 |
|
P190017
S027 |
30-Day Notice | LIAISON® MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg Qual And LIAISON® MUREX HBsAg Confirmatory |
DiaSorin Inc | 08/21/2025 |
|
P210032
S019 |
Normal 180 Day Track No User Fee |
GORE TAG Thoracic Branch Endoprosthesis (TBE Device) |
W. L. Gore & Associates, Inc. |
08/21/2025 |
|
P020004
S202 |
30-Day Notice | GORE® EXCLUDER® AAA Endoprosthesis | W.L. GORE & ASSOCIATES,INC |
08/20/2025 |
|
P080011
S184 |
Normal 180 Day Track No User Fee |
Up&up Monthly Performance + | CooperVision, Inc. | 08/20/2025 |
|
P080011
S186 |
Normal 180 Day Track No User Fee |
Iwear Oxygen Presbyopia | CooperVision, Inc. | 08/20/2025 |
|
P100009
S078 |
Special (Immediate Track) |
MitraClip G5 Delivery System | Abbott Medical | 08/20/2025 |
|
P100016
S022 |
30-Day Notice | CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P |
Carl Zeiss Meditec Production LLC |
08/20/2025 |
|
P120003
S010 |
30-Day Notice | Icast Covered Stent System | ATRIUM MEDICAL CORP. | 08/20/2025 |
|
P150033
S208 |
Real-Time Process | MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
MEDTRONIC Inc. | 08/20/2025 |
|
P160017
S122 |
Normal 180 Day Track No User Fee |
MiniMed 770G System | MEDTRONIC MINIMED, INC. | 08/20/2025 |
|
P170024
S024 |
30-Day Notice | Surpass Streamline Flow Diverter | Stryker Neurovascular | 08/20/2025 |
|
P200035
S025 |
Real-Time Process | OrganOx Metra® System | OrganOx Limited | 08/20/2025 |
|
P230007
S015 |
Special (Immediate Track) |
TriClip G5 Delivery System | Abbott Medical | 08/20/2025 |
|
P230022
S001 |
Normal 180 Day Track No User Fee |
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati |
Element Science, Inc. | 08/20/2025 |
|
P960058
S171 |
30-Day Notice | HiResolution™ Bionic Ear System | ADVANCED BIONICS | 08/20/2025 |
|
P170030
S055 |
Real-Time Process | Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 08/19/2025 |
|
P960004
S108 |
30-Day Notice | THINLINE ENDOCARDIAL PACING LEADS | BOSTON SCIENTIFIC | 08/19/2025 |
|
P060037
S095 |
30-Day Notice | NexGen© LPSFlex/ LPS Mobile Bearing Knee System |
ZIMMER, INC. | 08/18/2025 |
|
P100009
S079 |
30-Day Notice | MitraClip Delivery System | Abbott Medical | 08/18/2025 |
|
P100026
S099 |
30-Day Notice | NeuroPace® RNS® System | NEUROPACE INC | 08/18/2025 |
|
P230007
S016 |
30-Day Notice | TriClip Delivery System | Abbott Medical | 08/18/2025 |
|
P980044
S064 |
30-Day Notice | SUPARTZ FX | SEIKAGAKU CORP. | 08/18/2025 |
|
P110019
S136 |
30-Day Notice | XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra™ Everolimus Eluting Coronary Sten |
ABBOTT VASCULAR | 08/16/2025 |
| P250004 | Original | MMR IHC Panel Pharmdx (Dako Omnis) | Agilent Technologies, Inc. |
08/15/2025 |
| P250005 | Original | Idylla CDx MSI Test | Biocartis US, Inc. | 08/15/2025 |
|
P130022
S067 |
Normal 180 Day Track | Senza® HFX Iq™ System | Nevro Corporation | 08/15/2025 |
|
P150033
S212 |
Real-Time Process | Micra Transcatheter Pacing System (Micra AV/VR And Micra AV2/VR2) |
MEDTRONIC Inc. | 08/15/2025 |
|
P150035
S029 |
Normal 180 Day Track No User Fee |
AVEIR™ AR 2 LSP203A Leadless Pacemaker (LP) (atrial) |
Abbott Medical | 08/15/2025 |
|
P170008
S060 |
30-Day Notice | EluNIR™ Ridaforolimus Eluting Coronary Stent System |
Medinol, Ltd. | 08/15/2025 |
|
P240013
S013 |
Normal 180 Day Track No User Fee |
HexaGen™ RF Generator, HexaPulse™ PF Generator, HexaFlow™ Irrigation Pump |
Medtronic Inc. | 08/15/2025 |
|
P240031
S001 |
Normal 180 Day Track No User Fee |
Neuspera Sacral Neuromodulation System |
Neuspera Medical Inc | 08/15/2025 |
|
P000006
S071 |
Real-Time Process | Titan Inflatable Penile Prosthesis | COLOPLAST CORP. | 08/14/2025 |
|
P020025
S146 |
Normal 180 Day Track No User Fee |
Blazer™ II XP Cardiac Ablation Catheter And Cable |
BOSTON SCIENTIFIC | 08/14/2025 |
|
P050047
S105 |
30-Day Notice | Juvéderm Ultra XC, And Juvéderm Ultra Plus XC (hereafter Referred To As Ultra XC And Ultra Plus XC) |
Allergan | 08/14/2025 |
|
P060005
S022 |
30-Day Notice | IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA) |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED |
08/14/2025 |
|
P100018
S048 |
Normal 180 Day Track No User Fee |
Pipeline™ Vantage Embolization Device With Shield Technology™ |
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR |
08/14/2025 |
|
P110033
S101 |
30-Day Notice | Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC And SKINVIVE By Juvéderm (hereafter Ref |
Allergan | 08/14/2025 |
|
P130021
S177 |
30-Day Notice | Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni |
Medtronic, Inc. | 08/14/2025 |
|
P150005
S089 |
Normal 180 Day Track No User Fee |
Blazer™ Open-Irrigated Ablation Catheter |
Boston Scientific Corp. | 08/14/2025 |
|
P190009
S009 |
Normal 180 Day Track No User Fee |
OPRA™ Implant System | Integrum AB | 08/14/2025 |
|
P220032
S011 |
Normal 180 Day Track No User Fee |
POLARx™ Cryoablation System | Boston Scientific Corporation |
08/14/2025 |
|
P230001
S010 |
30-Day Notice | ColoSense® | Geneoscopy, Inc. | 08/14/2025 |
|
P230030
S014 |
Normal 180 Day Track No User Fee |
FARAPULSE™ Pulsed Field Ablation System |
FARAPULSE, Inc. | 08/14/2025 |
|
P230040
S017 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 08/14/2025 |
|
P840001
S602 |
30-Day Notice | Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™ |
MEDTRONIC NEUROMODULATION |
08/14/2025 |
|
P900056
S221 |
Normal 180 Day Track No User Fee |
ROTABLATOR™ Rotational Atherectomy System |
Boston Scientific Corp. | 08/14/2025 |
|
P920047
S137 |
Normal 180 Day Track No User Fee |
Blazer™ II Cardiac Ablation System And Cable |
Boston Scientific Corp. | 08/14/2025 |
|
P930027
S036 |
30-Day Notice | IMMULITE 2000 Prostate-Specific Antigen (PSA) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
08/14/2025 |
|
P010030
S196 |
30-Day Notice | LifeVest® Wearable Defibrillator, Model 4000 |
ZOLL MANUFACTURING CORPORATION |
08/13/2025 |
|
P060001
S051 |
30-Day Notice | Protege™ RX Carotid Stent System | MEDTRONIC VASCULAR INC | 08/13/2025 |
|
P130029
S013 |
30-Day Notice | FLUENCY PLUS ENDOVASCULAR STENT GRAFT |
BARD PERIPHERAL VASCULAR, INC. |
08/13/2025 |
|
P210015
S007 |
Real-Time Process | Avive Automated External Defibrillator (AED) System |
Avive Solutions, Inc. | 08/13/2025 |
|
P230013
S016 |
Normal 180 Day Track No User Fee |
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System |
Edwards Lifesciences LLC | 08/13/2025 |
|
P230042
S001 |
Real-Time Process | Optune Lua | Novocure GmbH | 08/12/2025 |
|
P010015
S568 |
30-Day Notice | Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CR T- |
MEDTRONIC Inc. | 08/12/2025 |
|
P010015
S569 |
30-Day Notice | Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Se |
MEDTRONIC Inc. | 08/12/2025 |
|
P010031
S898 |
30-Day Notice | Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
08/12/2025 |
|
P010031
S900 |
30-Day Notice | Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1;Brav |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
08/12/2025 |
|
P030053
S080 |
30-Day Notice | MemoryGel™ Silicone Gel-Filled Breast Implants |
MENTOR CORP. | 08/12/2025 |
|
P060028
S055 |
30-Day Notice | MemoryShape™ Silicone Gel-Filled Breast Implants |
MENTOR WORLDWIDE LLC | 08/12/2025 |
|
P090022
S046 |
30-Day Notice | Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM |
LENSTEC, INC. | 08/12/2025 |
|
P140010
S097 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
MEDTRONIC Inc. | 08/12/2025 |
|
P140010
S099 |
30-Day Notice | IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
MEDTRONIC Inc. | 08/12/2025 |
|
P150033
S214 |
30-Day Notice | Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 |
MEDTRONIC Inc. | 08/12/2025 |
|
P190008
S044 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
Medtronic Vascular Inc. | 08/12/2025 |
|
P200020
S009 |
30-Day Notice | ClearView 3 Lens | Lenstec, Inc. | 08/12/2025 |
|
P220012
S056 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 08/12/2025 |
|
P230030
S015 |
30-Day Notice | FARAPULSE™ Pulsed Field Ablation System |
FARAPULSE, Inc. | 08/12/2025 |
|
P890003
S482 |
30-Day Notice | CareLink SmartSync Device Manager Base |
Medtronic, Inc. | 08/12/2025 |
|
P980016
S932 |
30-Day Notice | Cobalt MRI ICD, Cobalt XT MRI ICD, Srome MRI ICD |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
08/12/2025 |
|
P980016
S934 |
30-Day Notice | Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
08/12/2025 |
|
P980035
S818 |
30-Day Notice | Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
MEDTRONIC Inc. | 08/12/2025 |
|
P980035
S820 |
30-Day Notice | Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED |
MEDTRONIC Inc. | 08/12/2025 |
|
P990075
S063 |
30-Day Notice | Saline And SPECTRUM™ Saline-Filled Breast Implants |
MENTOR WORLDWIDE LLC | 08/12/2025 |
| P240024 | Original | Genio® System 2.1 | Nyxoah S.A. | 08/08/2025 |
|
P030053
S082 |
30-Day Notice | MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants |
MENTOR CORP. | 08/08/2025 |
|
P060028
S056 |
30-Day Notice | MENTOR™ MemoryShape™ Breast Implants |
MENTOR WORLDWIDE LLC | 08/08/2025 |
|
P110035
S074 |
30-Day Notice | Epic™ Vascular Self-Expanding Stent System |
Boston Scientific Corp. | 08/08/2025 |
|
P140003
S124 |
135 Review Track For 30-Day Notice |
Impella CP With SmartAssist System | ABIOMED, INC. | 08/08/2025 |
|
P140028
S083 |
30-Day Notice | Lnnova™ Vascular Self Expanding Stent |
BOSTON SCIENTIFIC CORPORATION |
08/08/2025 |
|
P150041
S007 |
30-Day Notice | Vysis CLL Fish Probe Kit | ABBOTT MOLECULAR, INC. | 08/08/2025 |
|
P160045
S049 |
Normal 180 Day Track | Oncomine Dx Target Test | LIFE TECHNOLOGIES CORPORATION |
08/08/2025 |
|
P180011
S066 |
30-Day Notice | Eluvia™ Drug-Eluting Vascular Stent System |
Boston Scientific Corp. | 08/08/2025 |
|
P230036
S013 |
Normal 180 Day Track No User Fee |
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Abbott Medical | 08/08/2025 |
|
P990075
S064 |
30-Day Notice | MENTOR™ Saline-Filled And SPECTRUM™ Breast Implants |
MENTOR WORLDWIDE LLC | 08/08/2025 |
|
P010014
S109 |
Normal 180 Day Track | Oxford Partial Knee System | BIOMET MANUFACTURING CORP. |
08/07/2025 |
|
P010014
S111 |
30-Day Notice | Oxford™ Knee System | BIOMET MANUFACTURING CORP. |
08/07/2025 |
|
P020004
S201 |
30-Day Notice | EXCLUDER BIFURCATED ENDOPROSTHESIS | W.L. GORE & ASSOCIATES,INC |
08/07/2025 |
|
P150014
S057 |
30-Day Notice | Cobas® HBV | Roche Molecular Systems, Inc. |
08/07/2025 |
|
P170008
S059 |
30-Day Notice | EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System |
Medinol, Ltd. | 08/07/2025 |
|
P190028
S020 |
30-Day Notice | Cobas® HPV | Roche Molecular Systems, Inc. |
08/07/2025 |
|
P220013
S021 |
Real-Time Process | TactiFlex™ Ablation Catheter, Sensor Enabled™ |
Abbott Medical | 08/07/2025 |
|
P240006
S010 |
30-Day Notice | VARIPULSE™ Platform; VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; Ngen™ Pump |
Biosense Webster, Inc | 08/07/2025 |
|
P240040
S001 |
30-Day Notice | Oncomine™ Dx Express Test | Life Technologies Corporation |
08/07/2025 |
|
P930038
S106 |
30-Day Notice | Angio-Seal Vascular Closure Device | TERUMO MEDICAL CORPORATION |
08/07/2025 |
| P250012 | Original | Simplera Sync Sensor, Guardian 4 Sensor |
Medtronic MiniMed Inc. | 08/06/2025 |
|
P010015
S567 |
30-Day Notice | Consulta CRT-P (C4TR01); Syncra CRT-P (C2TR01) |
MEDTRONIC Inc. | 08/06/2025 |
|
P030053
S072 |
135 Review Track For 30-Day Notice |
Mentor MemoryGel® Breast Implants | MENTOR CORP. | 08/06/2025 |
|
P080025
S327 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
08/06/2025 |
|
P840001
S603 |
30-Day Notice | Master Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems |
MEDTRONIC NEUROMODULATION |
08/06/2025 |
|
P960009
S515 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 08/06/2025 |
|
P970004
S432 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
08/06/2025 |
|
P970051
S235 |
30-Day Notice | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 08/06/2025 |
|
P980035
S817 |
30-Day Notice | Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01) |
MEDTRONIC Inc. | 08/06/2025 |
|
P000057
S014 |
30-Day Notice | ASCENSION MCP | Smith & Nephew, Inc. | 08/05/2025 |
|
P070026
S121 |
30-Day Notice | CERAMAX CERAMIC HIP SYSTEM | DEPUY ORTHOPAEDICS, INC. | 08/05/2025 |
|
P110012
S022 |
Normal 180 Day Track | Vysis ALK Break Apart FISH Probe Kit | ABBOTT MOLECULAR, INC. | 08/05/2025 |
|
P110023
S056 |
Normal 180 Day Track | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) |
MEDTRONIC VASCULAR INC | 08/05/2025 |
|
P140002
S029 |
30-Day Notice | MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System |
TERUMO MEDICAL CORPORATION |
08/05/2025 |
|
P180025
S014 |
30-Day Notice | MANTA™ Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L |
Teleflex Medical LLC | 08/05/2025 |
|
P220020
S007 |
Real-Time Process | Lava Liquid Embolic System (Lava LES) And Lava Mixing Kit |
BlackSwan Vascular, Inc. | 08/05/2025 |
| P250003 | Original | Embrace(TM) Hydrogel Embolic System | Instylla Inc. | 08/05/2025 |
|
P830055
S347 |
30-Day Notice | LCS® Total Knee System | DEPUY, INC. | 08/05/2025 |
|
BP130026
S024 |
30-Day Notice | Immucor PreciseType™ Human Erythrocyte Antigen Molecular BeadChip Test |
BioArray Solutions, Ltd. | 08/05/2025 |
|
P010051
S023 |
30-Day Notice | IMMULITE 2000 Systems Total Antibodies To Hepatitis B Core Antigen (Anti-HBc) |
Siemens Healthcare Diagnostics Products, LTD |
08/04/2025 |
|
P030054
S438 |
30-Day Notice | Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); |
Abbott Medical | 08/04/2025 |
|
P070006
S027 |
Real-Time Process | T-SPOT.TB TEST | OXFORD IMMUNOTEC,LTD. | 08/04/2025 |
|
P070006
S028 |
30-Day Notice | T-SPOT.TB Test | OXFORD IMMUNOTEC,LTD. | 08/04/2025 |
|
P150013
S028 |
Normal 180 Day Track | PD-L1 IHC 22C3 Pharmdx (Dako Omnis) | Agilent Technologies, Inc. |
08/04/2025 |
|
P210005
S011 |
Special (Immediate Track) |
IC-8 Apthera Intraocular Lens (IOL) | AcuFocus, Inc. | 08/04/2025 |
|
P910023
S481 |
30-Day Notice | Avant™ VR (CDVRA700Q, CDVRA700T); Neutrino™ NxT VR (CDVRA800Q, CDVRA800T CDVRA600Q, CDVRA600T); Gallant™ VR (CDVRA500Q, |
Abbott Medical | 08/04/2025 |
|
P070026
S122 |
30-Day Notice | CERAMAX CERAMIC HIP SYSTEM | DEPUY ORTHOPAEDICS, INC. | 08/01/2025 |
|
P080025
S326 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
08/01/2025 |
|
P140003
S123 |
Normal 180 Day Track No User Fee |
Impella 5.5 With SmartAssist System; Impella CP With SmartAssist System; Impella 2.5; Impella 5.0; Impella LD; |
ABIOMED, INC. | 08/01/2025 |
|
P170011
S056 |
Normal 180 Day Track No User Fee |
Impella RP System; Impella RP With SmartAssist System; Impella RP Flex With SmartAssist System; |
Abiomed, Inc. | 08/01/2025 |
|
P220013
S020 |
Real-Time Process | TactiFlex™ Ablation Catheter, Sensor Enabled™ |
Abbott Medical | 08/01/2025 |
|
P240013
S008 |
Real-Time Process | AFR-00004 HexaGen RF Generator (RFG) And AFR-00008 HexaPulse PF Generator (PFG) |
Medtronic Inc. | 08/01/2025 |
|
P970004
S431 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
08/01/2025 |
|
P980037
S095 |
30-Day Notice | AngioJet Thrombectomy System | Boston Scientific Corp. | 08/01/2025 |
|
P190024
S014 |
Real-Time Process | CINtec PLUS Cytology | Ventana Medical Systems, Inc. |
07/31/2025 |
|
P890023
S055 |
30-Day Notice | Biomedics 55 Asphere; Biomedics Toric |
THE COOPER COMPANIES | 07/31/2025 |
| P240039 | Original | SetPoint System | SetPoint Medical | 07/30/2025 |
|
P050010
S028 |
30-Day Notice | Prodisc L | Centinel Spine, LLC | 07/30/2025 |
|
P070001
S029 |
30-Day Notice | Prodisc® C | Centinel Spine, LLC | 07/30/2025 |
|
P180035
S030 |
30-Day Notice | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 07/30/2025 |
|
P210006
S013 |
30-Day Notice | Thoraflex™ Hybrid | Vascutek Ltd. | 07/30/2025 |
|
P240005
S003 |
135 Review Track For 30-Day Notice |
Envista Envy™ Hydrophobic Acrylic Intraocular Lens (IOL), Envista Envy™ Toric Hydrophobic Acrylic Intraocular Lens (IOL) |
Bausch & Lomb, Inc. | 07/30/2025 |
|
P010031
S899 |
30-Day Notice | Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/29/2025 |
|
P040021
S059 |
30-Day Notice | Epic™ Plus Stented Tissue Valve; Epic™ Max Stented Tissue Valve |
Abbott Medical | 07/29/2025 |
|
P150033
S213 |
30-Day Notice | MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
MEDTRONIC Inc. | 07/29/2025 |
|
P190023
S026 |
30-Day Notice | Navitor™ Transcatheter Aortic Valve |
Abbott Medical | 07/29/2025 |
|
P220012
S055 |
30-Day Notice | Aurora EV-ICD System | Medtronic, Inc. | 07/29/2025 |
