| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P100045
S082 |
135 Review Track For 30-Day Notice |
CardioMEMS™ HF System | Abbott Medical | 01/09/2026 |
|
P150012
S177 |
30-Day Notice | INGEVITY™ Family Bradycardia Leads | Boston Scientific | 01/09/2026 |
|
P230040
S025 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 01/09/2026 |
|
P240044
S004 |
30-Day Notice | Globe® Catheter; Globe® Pulsed Field System |
Kardium, Inc. | 01/09/2026 |
|
N970003
S301 |
135 Review Track For 30-Day Notice |
Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, |
Boston Scientific Corp | 01/08/2026 |
|
P010012
S592 |
135 Review Track For 30-Day Notice |
NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode |
Boston Scientific Corp | 01/08/2026 |
|
P020036
S059 |
30-Day Notice | S.M.A.R.T.® And S.M.A.R.T.® CONTROL® Vascular Stent System; S.M.A.R.T. RADIANZ™ Vascular Stent System |
Cordis US Corporation | 01/08/2026 |
|
P030005
S247 |
135 Review Track For 30-Day Notice |
Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 |
Guidant Corp. | 01/08/2026 |
|
P030036
S155 |
30-Day Notice | SelectSecure Lead 3830 | Medtronic Cardiac Rhythm Disease Management |
01/08/2026 |
|
P030047
S053 |
30-Day Notice | PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System |
Cordis US Corporation | 01/08/2026 |
|
P070026
S118 |
135 Review Track For 30-Day Notice |
Ceramax® Ceramic Total Hip System | DePuy Orthopaedics, Inc. | 01/08/2026 |
|
P100013
S033 |
30-Day Notice | EXOSEAL® Vascular Closure Device | Cordis US Corporation | 01/08/2026 |
|
P110016
S091 |
30-Day Notice | FlexAbility™ Ablation Catheter (Flex) And FlexAbility™ Ablation Catheter, Sensor Enabled™ (Flex SE) |
Abbott Medical | 01/08/2026 |
|
P110042
S204 |
135 Review Track For 30-Day Notice |
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 And EMBLEM MRI S-ICD Model A219 |
Boston Scientific Corporation |
01/08/2026 |
|
P120002
S034 |
30-Day Notice | S.M.A.R.T.® And S.M.A.R.T.® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System |
Cordis US Corporation | 01/08/2026 |
|
P130026
S097 |
30-Day Notice | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) |
St Jude Medical | 01/08/2026 |
|
P140026
S033 |
30-Day Notice | ENROUTE Transcarotid Stent System | Boston Scientific Corporation |
01/08/2026 |
|
P150012
S169 |
135 Review Track For 30-Day Notice |
Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models: |
Boston Scientific | 01/08/2026 |
|
P160008
S032 |
30-Day Notice | HeartSine’s Samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P And SAM 450P) And Accessories |
Heartsine Technologies, Ltd. |
01/08/2026 |
|
P220013
S025 |
30-Day Notice | TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) |
Abbott Medical | 01/08/2026 |
|
P220030
S009 |
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 | 01/08/2026 |
|
P230012
S009 |
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 | 01/08/2026 |
|
P960040
S505 |
135 Review Track For 30-Day Notice |
NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152, D153; INOG |
Boston Scientific | 01/08/2026 |
|
P080011
S194 |
30-Day Notice | Comfilcon A Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 01/07/2026 |
|
P180003
S013 |
30-Day Notice | BioMimics 3D® Vascular Stent System | Veryan Medical, Ltd. | 01/07/2026 |
|
P180046
S102 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
01/07/2026 |
|
P190006
S102 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
01/07/2026 |
|
P220025
S008 |
30-Day Notice | LimFlow System | LimFlow, Inc. | 01/07/2026 |
|
P230042
S005 |
30-Day Notice | Optune Lua® | Novocure, GmbH | 01/07/2026 |
|
P100013
S032 |
30-Day Notice | EXOSEAL® Vascular Closure Device | Cordis US Corporation | 01/06/2026 |
|
P190002
S036 |
Normal 180 Day Track No User Fee |
Saluda Medical Evoke SCS System | Saluda Medical Pty. , Ltd. |
01/06/2026 |
|
P200019
S013 |
30-Day Notice | VENTANA Anti-msh6 (SP93) Antibody | Ventana Medical Systems | 01/06/2026 |
|
P210001
S015 |
30-Day Notice | VENTANA Anti-msh6 (SP93) Antibody | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
01/06/2026 |
|
P230003
S010 |
30-Day Notice | Alinity M HR HPV | Abbott Molecular, Inc. | 01/06/2026 |
|
P230043
S003 |
30-Day Notice | Stool DNA (sDNA) Test, Cologuard Plus™ |
Exact Sciences Corporation |
01/06/2026 |
|
P240044
S003 |
30-Day Notice | Globe® Pulsed Field System | Kardium, Inc. | 01/06/2026 |
|
P000037
S068 |
30-Day Notice | On-X Prosthetic Heart Valves And Ascending Aortic Prothesis |
On-X Life Technologies, Inc. |
01/05/2026 |
|
P010031
S911 |
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 |
01/05/2026 |
|
P140008
S028 |
Normal 180 Day Track No User Fee |
ORBERA INTRAGASTRIC BALLOON | Boston Scientific Corporation |
01/05/2026 |
|
P220012
S063 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 01/05/2026 |
| P240014 | Original | MAGiC Ablation Catheter | Stereotaxis, Inc. | 01/05/2026 |
|
P980016
S944 |
30-Day Notice | Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4 Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 Crome MRI ICD DDP |
Medtronic Cardiac Rhythm Disease Management |
01/05/2026 |
|
P030053
S086 |
30-Day Notice | MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants |
Mentor Corp. | 01/02/2026 |
|
P060028
S059 |
30-Day Notice | MENTOR™ MemoryShape™ Breast Implants |
Mentor Worldwide, LLC | 01/02/2026 |
|
P170023
S023 |
30-Day Notice | Bulkamid Urethral Bulking System | Boston Scientific Corporation |
01/02/2026 |
|
P240006
S013 |
30-Day Notice | VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; Ngen™ Pump |
Biosense Webster, Inc. | 01/02/2026 |
|
P000057
S013 |
135 Review Track For 30-Day Notice |
Ascension MCP | Smith & Nephew, Inc. | 12/31/2025 |
|
P100020
S064 |
30-Day Notice | Cobas® HPV | Roche Molecular Systems, Inc. |
12/31/2025 |
|
P110020
S043 |
30-Day Notice | Cobsa® BRAF V600 Mutation Test | Roche Molecular Systems, Inc. |
12/31/2025 |
|
P120019
S042 |
30-Day Notice | Cobas® EGFR Mutation Test, V2.0 | Roche | 12/31/2025 |
|
P140023
S031 |
30-Day Notice | Cobas® KRAS Mutation Test | Roche Molecular Systems, Inc. |
12/31/2025 |
|
P190028
S022 |
30-Day Notice | Cobas® HPV | Roche Molecular Systems, Inc. |
12/31/2025 |
|
P200014
S010 |
30-Day Notice | Cobas® EZH2 Mutation Test | Roche Molecular System, Inc. |
12/31/2025 |
| P250010 | Original | Proliv™Rx System | Neurolief , Ltd. | 12/31/2025 |
|
P160022
S049 |
30-Day Notice | OneStep CPR Complete Electrode | ZOLL Medical Corporation | 12/30/2025 |
|
P200010
S028 |
30-Day Notice | Guardant360 CDx | Guardant Health, Inc. | 12/29/2025 |
|
P010032
S246 |
30-Day Notice | Proclaim™ Spinal Cord Stimulation (SCS) System |
Abbott Medical | 12/23/2025 |
|
P040024
S146 |
Normal 180 Day Track No User Fee |
Restylane® Lyft With Lidocaine | Q-Med AB | 12/23/2025 |
|
P060011
S043 |
30-Day Notice | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) |
Rayner Intraocular Lenses , Ltd. |
12/23/2025 |
|
P080025
S337 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
12/23/2025 |
|
P130026
S096 |
Real-Time Process | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ |
St Jude Medical | 12/23/2025 |
|
P140009
S127 |
30-Day Notice | Infinity™ Deep Brain Stimulation (DBS) System |
Abbott Medical | 12/23/2025 |
|
P150004
S092 |
30-Day Notice | Proclaim Dorsal Root Ganglion (DRG) System |
Abbott Medical | 12/23/2025 |
|
P170007
S015 |
30-Day Notice | DUROLANE | Bioventus, LLC | 12/23/2025 |
|
P170016
S001 |
30-Day Notice | SYNOJOYNT™ | Arthrex, Inc. | 12/23/2025 |
|
P180035
S033 |
30-Day Notice | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 12/23/2025 |
|
P200049
S014 |
Real-Time Process | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Abbott Medical | 12/23/2025 |
|
P220021
S008 |
30-Day Notice | DETOUR System | Endologix, LLC | 12/23/2025 |
|
P240006
S012 |
Real-Time Process | TRUPULSE™ Generator | Biosense Webster, Inc. | 12/23/2025 |
|
P830063
S031 |
30-Day Notice | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC |
12/23/2025 |
|
BP130076
S086 |
30-Day Notice | INTERCEPT(R) Blood System For Plasma | Cerus Corporation | 12/23/2025 |
|
BP140143
1152 |
30-Day Notice | INTERCEPT(R) Blood Systerm For Platelets |
Cerus Corporation | 12/23/2025 |
|
P970004
S442 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
Medtronic Neuromodulation |
12/23/2025 |
|
P990071
S068 |
Real-Time Process | Ngen™ Pump | Biosense Webster, Inc. | 12/23/2025 |
| P250019 | Original | SAPIEN M3 Transcatheter Mitral Valve Replacement System |
Edwards Lifesciences, LLC |
12/22/2025 |
|
P080025
S336 |
30-Day Notice | InterStim Therapy System; Verify Evaluation System |
Medtronic Neuromodulation |
12/22/2025 |
|
P120003
S009 |
Normal 180 Day Track | Icast Covered Stent System | Atrium Medical Corp. | 12/22/2025 |
|
P150011
S035 |
30-Day Notice | Perceval Sutureless Heart Valve | Corcym S.R.L. | 12/22/2025 |
|
P160008
S031 |
30-Day Notice | Samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P And SAM 450P) And Accessories |
Heartsine Technologies, Ltd. |
12/22/2025 |
|
P160042
S029 |
30-Day Notice | Revanesse Versa; Revanesse Versa+ (with Lidocaine); Revanesse Lips+ (with Lidocaine) |
Prollenium Medical Technologies, Inc. |
12/22/2025 |
|
P230009
S011 |
30-Day Notice | Shield | Guardant Health, Inc. | 12/22/2025 |
|
P840001
S616 |
30-Day Notice | Master Restore; Itrel; Synergy; Intellis; Vanta And Inceptiv Spinal Cord Stimulation Systems And Pisces; Specify; And Ve |
Medtronic Neuromodulation |
12/22/2025 |
|
P860004
S455 |
30-Day Notice | SynchroMed Infusion System; Ascenda Intrathecal Catheters |
Medtronic, Inc. | 12/22/2025 |
|
P910071
S019 |
30-Day Notice | ADATO SIL-OL 5000 Silicone Oils | Bausch & Lomb | 12/22/2025 |
|
P960009
S527 |
30-Day Notice | Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense |
Medtronic, Inc. | 12/22/2025 |
|
P970004
S441 |
30-Day Notice | InterStim Therapy System; Verify Evaluation System |
Medtronic Neuromodulation |
12/22/2025 |
| P250022 | Original | Volt™ PFA System | Abbott Medical | 12/19/2025 |
| P250017 | Original | GORE® VIABAHN® FORTEGRA Venous Stent |
W.L. Gore & Associates, Inc. |
12/19/2025 |
|
N970003
S304 |
Real-Time Process | ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( |
Boston Scientific Corp | 12/19/2025 |
|
P010015
S574 |
Normal 180 Day Track | Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol |
Medtronic, Inc. | 12/19/2025 |
|
P010031
S905 |
Normal 180 Day Track | Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4 |
Medtronic Cardiac Rhythm Disease Management |
12/19/2025 |
|
P030005
S250 |
Real-Time Process | VALITUDE™ (Model U125) VALITUDE™ X4 (Model U128) VISIONIST™ (Models U225, U226) VISIONIST™ X4 (Model U228) Firmware Vers |
Guidant Corp. | 12/19/2025 |
|
P050006
S116 |
30-Day Notice | GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder |
W.L. Gore & Associates, Inc. |
12/19/2025 |
|
P060019
S058 |
30-Day Notice | Cool Point™ Tubing Set | Irvine Biomedical, Inc. | 12/19/2025 |
|
P140003
S136 |
30-Day Notice | Impella CP With SmartAssist; Impella 5.5 With SmartAssist |
Abiomed, Inc. | 12/19/2025 |
|
P150012
S173 |
Real-Time Process | ESSENTIO™ MRI (Models L110, L111, L131) PROPONENT™ MRI (Models L210, L211, L231) ACCOLADE™ MRI (Models L310, L311, L331) |
Boston Scientific | 12/19/2025 |
|
P160035
S055 |
30-Day Notice | EXCOR Pediatric Ventricular Assist Device |
Berlin Heart, Inc. | 12/19/2025 |
|
P160043
S089 |
30-Day Notice | Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX And OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S |
Medtronic Vascular | 12/19/2025 |
|
P170011
S062 |
30-Day Notice | Impella CP With SmartAssist; Impella 5.5 With SmartAssist |
Abiomed, Inc. | 12/19/2025 |
|
P180046
S101 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
12/19/2025 |
|
P180047
S041 |
30-Day Notice | LIAISON® QuantiFERON-TB Gold Plus And LIAISON® Control QuantiFERON-TB Gold Plus |
DiaSorin, Inc. | 12/19/2025 |
|
P190006
S101 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
12/19/2025 |
|
P200007
S002 |
30-Day Notice | HeartSync Multifunction Disposable Single-Use Defibrillator Pads |
Graphic Controls D.B.A. Vermed |
12/19/2025 |
|
P220034
S008 |
30-Day Notice | LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus |
DiaSorin, Inc. | 12/19/2025 |
|
P230040
S015 |
Normal 180 Day Track | CorPASS System | Endotronix, Inc. | 12/19/2025 |
|
P230044
S002 |
Real-Time Process | Alfapump System | Sequana Medical NV | 12/19/2025 |
|
P240011
S004 |
Normal 180 Day Track No User Fee |
Medtronic Altaviva System | Medtronic Neuromodulation |
12/19/2025 |
|
P240022
S004 |
Real-Time Process | Evolysse Injectable Hyaluronic Acid | Symatese | 12/19/2025 |
|
P860004
S453 |
Normal 180 Day Track | SynchroMed™ Infusion Systems | Medtronic, Inc. | 12/19/2025 |
|
P970051
S240 |
30-Day Notice | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | Cochlear Americas | 12/19/2025 |
|
P980044
S065 |
30-Day Notice | SUPARTZ FX; VISCO-3 | Seikagaku Corp. | 12/19/2025 |
|
P160015
S025 |
Normal 180 Day Track No User Fee |
AED 3™ | ZOLL Medical Corporation | 12/18/2025 |
|
P160022
S046 |
Normal 180 Day Track No User Fee |
X Series®; Propaq MD®; AED 3™ BLS; Zenix Professional Defibrillators |
ZOLL Medical Corporation | 12/18/2025 |
|
BP170154
S044 |
30-Day Notice | ID CORE XT | Progenika Biopharma, S.A. |
12/18/2025 |
|
P000009
S120 |
Normal 180 Day Track | Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014 |
Biotronik, Inc. | 12/18/2025 |
|
P010047
S072 |
30-Day Notice | PROGEL™ Pleural Air Leak Sealant | Neomend, Inc. | 12/18/2025 |
|
P030017
S374 |
Real-Time Process | WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor |
Boston Scientific Corp | 12/18/2025 |
|
P030039
S032 |
30-Day Notice | Coseal Applicator Tips | Baxter Bio Science | 12/18/2025 |
|
P050023
S199 |
Normal 180 Day Track | Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q |
Biotronik, Inc. | 12/18/2025 |
|
P130013
S082 |
30-Day Notice | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device With Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl |
Boston Scientific Corp | 12/18/2025 |
|
P150006
S007 |
30-Day Notice | CELT ACD Vascular Closure Device | Vasorum, Ltd. | 12/18/2025 |
|
P150016
S027 |
30-Day Notice | TRIDYNE™ Vascular Sealant | Neomend, Inc. | 12/18/2025 |
|
P150040
S020 |
Normal 180 Day Track No User Fee |
VisuMax; VISUMAX 800 | Carl Zeiss Meditec, Inc. | 12/18/2025 |
|
P160017
S133 |
Normal 180 Day Track No User Fee |
MiniMed 670G System | Medtronic Minimed, Inc. | 12/18/2025 |
|
P160050
S011 |
30-Day Notice | Barricaid® Annular Closure Device | Intrinsic Therapeutics | 12/18/2025 |
|
P180032
S022 |
Special (Immediate Track) |
Cerene® Cryotherapy Device | Channel Medsystems, Inc. | 12/18/2025 |
|
P200032
S004 |
30-Day Notice | Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack |
Occlutech Holding AG | 12/18/2025 |
|
P240003
S005 |
30-Day Notice | Minima Stent System | Renata Medical, Inc. | 12/18/2025 |
|
P240022
S003 |
Normal 180 Day Track No User Fee |
Evolysse® FORM | Symatese | 12/18/2025 |
|
P830055
S346 |
Normal 180 Day Track | ATTUNE™ Revision Rotating Platform (RP) Knee System |
Depuy, Inc. | 12/18/2025 |
|
P840001
S614 |
30-Day Notice | Master Restore, Itrel, Synergy Intellis, Vanta And Inceptiv Spinal Cord Stimulation Systems And Pisces, Specify, And Vec |
Medtronic Neuromodulation |
12/18/2025 |
|
P910001
S125 |
30-Day Notice | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 12/18/2025 |
|
P950037
S274 |
Normal 180 Day Track | Solia S 53 377177; Solia S 60 377179 | Biotronik, Inc. | 12/18/2025 |
|
P960009
S526 |
30-Day Notice | Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense |
Medtronic, Inc. | 12/18/2025 |
|
P960042
S073 |
30-Day Notice | GlideLight Laser Sheath | Spectranetics (Philips) | 12/18/2025 |
|
P980023
S136 |
Normal 180 Day Track | Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor Sky VR-T D |
Biotronik, Inc. | 12/18/2025 |
|
N970003
S305 |
30-Day Notice | ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) |
Boston Scientific Corp | 12/17/2025 |
|
P000037
S067 |
30-Day Notice | On-X Ascending Aortic Prosthesis | On-X Life Technologies, Inc. |
12/17/2025 |
|
P010013
S094 |
30-Day Notice | NovaSure Model 10 RF Controller | Hologic, Inc. | 12/17/2025 |
|
P030005
S251 |
30-Day Notice | VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228) |
Guidant Corp. | 12/17/2025 |
|
P030011
S096 |
Real-Time Process | SynCardia Total Artificial Heart (STAH) System |
Syncardia Systems, LLC | 12/17/2025 |
|
P030017
S390 |
30-Day Notice | Precision Spinal Cord Stimulator (SCS) Systems |
Boston Scientific Corp | 12/17/2025 |
|
P030053
S084 |
30-Day Notice | MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants |
Mentor Corp. | 12/17/2025 |
|
P040034
S040 |
30-Day Notice | DuraSeal Dural Sealant System | Integra LifeSciences Corporation |
12/17/2025 |
|
P060028
S057 |
30-Day Notice | MENTOR™ MemoryShape™ Breast Implants |
Mentor Worldwide, LLC | 12/17/2025 |
|
P060040
S122 |
30-Day Notice | HeartMate II™ Left Ventricular Assist System |
Abbott Medical | 12/17/2025 |
|
P080013
S029 |
30-Day Notice | DuraSeal Exact Spine Sealant System | Integra LifeSciences Corporation |
12/17/2025 |
|
P130008
S132 |
30-Day Notice | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | 12/17/2025 |
|
P140030
S022 |
30-Day Notice | Astron | Biotronik, Inc. | 12/17/2025 |
|
P140031
S196 |
30-Day Notice | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc |
Edwards Lifesciences, LLC |
12/17/2025 |
|
P140031
S197 |
30-Day Notice | Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, And 9755RSL29 |
Edwards Lifesciences, LLC |
12/17/2025 |
|
P150012
S175 |
30-Day Notice | ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331) |
Boston Scientific | 12/17/2025 |
|
P150031
S090 |
30-Day Notice | Vercise Deep Brain Stimulation (DBS) Systems |
Boston Scientific Corp | 12/17/2025 |
|
P150048
S095 |
30-Day Notice | Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, And 29mm; Edwards KONECT RESILI |
Edwards Lifesciences, LLC |
12/17/2025 |
|
P160025
S023 |
30-Day Notice | Astron Pulsar; Pulsar-18; Pulsar-18 T3 |
Biotronik, Inc. | 12/17/2025 |
|
P160054
S116 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 12/17/2025 |
|
P180035
S032 |
Normal 180 Day Track No User Fee |
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 12/17/2025 |
|
P200035
S031 |
30-Day Notice | OrganOx Metra® System | Organox Limited | 12/17/2025 |
|
P230005
S003 |
30-Day Notice | Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants |
Motiva, USA, LLC | 12/17/2025 |
|
P240020
S003 |
Normal 180 Day Track No User Fee |
TOUCH® CMC 1 Prosthesis | Keri Medical SA | 12/17/2025 |
|
P250003
S002 |
30-Day Notice | Embrace™ Hydrogel Embolic System (HES) |
Instylla, Inc. | 12/17/2025 |
|
P900060
S069 |
30-Day Notice | Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros |
Corcym S.R.L. | 12/17/2025 |
|
P960009
S514 |
Normal 180 Day Track No User Fee |
Activa™ Deep Brain Stimulation Therapy System |
Medtronic, Inc. | 12/17/2025 |
|
P970003
S252 |
30-Day Notice | VNS THERAPY SYSTEM | Liva Nova USA, Inc. | 12/17/2025 |
|
P990075
S066 |
30-Day Notice | MENTOR™ Saline-Filled And SPECTRUM™ Breast Implants |
Mentor Worldwide, LLC | 12/17/2025 |
|
N18033
S112 |
30-Day Notice | ACUVUE CONTACT LENS | Vistakon, Johnson & Johnson Vision Products, Inc. |
12/16/2025 |
|
P010062
S015 |
30-Day Notice | Boston Orthokeratology (oprifocon A) | Bausch & Lomb | 12/16/2025 |
|
P040045
S141 |
30-Day Notice | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
Vistakon, Division of Johnson & Johnson Vision Car |
12/16/2025 |
|
P060001
S053 |
30-Day Notice | Protégé™ GPS™ Self-expanding Peripheral Stent System |
Medtronic Vascular, Inc. | 12/16/2025 |
|
P070014
S066 |
30-Day Notice | LifeStent® Vascular Stent Systems | Bard Peripheral Vascular, Inc. |
12/16/2025 |
|
P160013
S020 |
Special (Immediate Track) |
Organ Care System™ (OCS™) Lung System |
TransMedics, Inc. | 12/16/2025 |
|
P170042
S014 |
30-Day Notice | Covera™ Vascular Covered Stent | C.R. Bard, Inc. | 12/16/2025 |
|
P180051
S009 |
Special (Immediate Track) |
Organ Care System™ (OCS™) Heart | TransMedics, Inc. | 12/16/2025 |
|
P200031
S012 |
Special (Immediate Track) |
Organ Care System™ (OCS™) Liver | TransMedics, Inc. | 12/16/2025 |
|
P810031
S081 |
30-Day Notice | Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht |
Johnson & Johnson Surgical Vision, Inc. |
12/16/2025 |
|
P860022
S061 |
30-Day Notice | Boston Equalens (itaflurofocon A) And Boston Equalens II (oprifocon A) |
Bausch & Lomb | 12/16/2025 |
|
P980040
S179 |
30-Day Notice | TECNIS SIMPLICITY™ Delivery System | Johnson & Johnson Surgical Vision, Inc. |
12/16/2025 |
|
P990040
S034 |
Panel Track | TRUFILL N-bca Liquid Embolic System (LES), TRUFILL N-bca Liquid Embolic System Procedural Set |
Cerenovus, Inc. | 12/16/2025 |
| P240035 | Original | ETHIZIA | Ethicon, Inc. | 12/15/2025 |
|
P010031
S909 |
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 |
12/15/2025 |
|
P100020
S063 |
30-Day Notice | COBAS HPV TEST | Roche Molecular Systems, Inc. |
12/15/2025 |
|
P130013
S078 |
Normal 180 Day Track No User Fee |
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Delivery System |
Boston Scientific Corp | 12/15/2025 |
|
P130013
S079 |
Normal 180 Day Track No User Fee |
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Delivery System |
Boston Scientific Corp | 12/15/2025 |
|
P150046
S006 |
30-Day Notice | Nevisense | Scibase AB | 12/15/2025 |
|
P190031
S014 |
Normal 180 Day Track | HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. |
12/15/2025 |
|
P220012
S061 |
30-Day Notice | Aurora EV-ICD System | Medtronic, Inc. | 12/15/2025 |
|
P220029
S003 |
Normal 180 Day Track No User Fee |
Optilume™ BPH Catheter System | Urotronic, Inc. | 12/15/2025 |
|
P230019
S001 |
Normal 180 Day Track | MediBeacon® Transdermal GFR Measurement System (TGFR) |
Medibeacon, Inc. | 12/15/2025 |
|
P240028
S004 |
30-Day Notice | WiSE® (Wireless Stimulation Of The Endocardium Technology) CRT System |
EBR Systems, Inc. | 12/15/2025 |
|
P830055
S355 |
30-Day Notice | LCS Total Knee System | Depuy, Inc. | 12/15/2025 |
|
P980016
S942 |
30-Day Notice | Cobalt MRI ICD DDPB3D4, DVPB3D4; Cobalt XT MRI ICD DDPA2D4, DVPA2D4; Crome MRI ICD DDPC3D4, DVPC3D4; Evera MRI DF-1 ICD |
Medtronic Cardiac Rhythm Disease Management |
12/15/2025 |
|
P990081
S059 |
Normal 180 Day Track | PATHWAY Anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
Ventana Medical Systems, Inc. |
12/15/2025 |
|
P140002
S031 |
Real-Time Process | MISAGO® RX Self-expanding Peripheral Stent |
Terumo Medical Corporation |
12/12/2025 |
|
N12159
S127 |
30-Day Notice | SURGICEL® Absorbable Hemostats | Ethicon, Inc. | 12/12/2025 |
|
P040020
S117 |
30-Day Notice | AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses |
Alcon Research, Ltd. | 12/12/2025 |
|
P040047
S079 |
30-Day Notice | COAPTITE | Merz North America, Inc. | 12/12/2025 |
|
P050037
S148 |
30-Day Notice | RADIESSE 1.3CC AND 0.3CC | Merz North America, Inc. | 12/12/2025 |
|
P050052
S173 |
30-Day Notice | RADIESSE INJECTABLE IMPLANT | Merz North America, Inc. | 12/12/2025 |
|
P130013
S080 |
30-Day Notice | WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device With Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage ( |
Boston Scientific Corp | 12/12/2025 |
|
P190018
S045 |
30-Day Notice | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) And Clareon PanOptix Hydrophobic Acrylic IOL |
Alcon Laboratories, LLC | 12/12/2025 |
