| Micra AV TPS and Micra TPS (P150033/S158) | Medtronic, Inc. | 2022-11-14 |
| Micra AV TPS, Micra TPS (P150033/S160) | Medtronic, Inc. | 2022-11-11 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S015) | Boston Scientific Corporation | 2022-11-10 |
| HeartMate II Left Ventricular Assist System (P060040/S088) | ABBOTT MEDICAL | 2022-11-10 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S035) | Physio-Control, Inc. | 2022-11-10 |
| Tack Endovascular System (4F, 1.5-4.5mm) (P190027/S005) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2022-11-09 |
| Arctic Fron Advance® Cardiac CryoAblation Catheters (P100010/S132) | Medtronic Cryocath, LP | 2022-11-09 |
| PorticoTM Transcatheter Aortic Valve Implantation System (P190023/S010) | ABBOTT MEDICAL | 2022-11-09 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S129) | Boston Scientific | 2022-11-08 |
| VenaSeal Closure System (P140018/S035) | Medtronic Vascular, Inc. | 2022-11-08 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S275) | Boston Scientific Corp | 2022-11-08 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S220) | Guidant Corp. | 2022-11-08 |
| Cardiva VASCADE Family (P120016/S030) | Cardiva Medical, Inc. | 2022-11-08 |
| INNOVA Vascular Self-Expanding Stent System (P140028/S075) | Boston Scientific Corporation | 2022-11-07 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S055) | Boston Scientific Corp | 2022-11-07 |
| EPIC Vascular Self-Expanding Stent System (P110035/S068) | Boston Scientific Corp | 2022-11-07 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S129) | Boston Scientific Corp | 2022-11-07 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S051) | Boston Scientific Corp | 2022-11-07 |
| Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) (P210039) | Trireme Medical, LLC | 2022-11-04 |
| Duett Sealing Device (D-Stat Flowable) (P990037/S036) | Vascular Solutions, Inc. | 2022-11-04 |
| Micra AV TPS, Micra TPS (P150033/S155) | Medtronic, Inc. | 2022-11-04 |
| 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 (P010031/S805) | Medtronic Cardiac Rhythm Disease Management | 2022-11-03 |
| Medtronic CoreValve Evolut R DCS (EnVeo R DCS), Medtronic CoreValve Evolut PRO DCS (EnVeo PRO DCS), Medtronic Evolut (P130021/S123) | Medtronic, Inc. | 2022-11-03 |
| Micra AV TPS, Micra TPS (P150033/S156) | Medtronic, Inc. | 2022-11-03 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S839) | Medtronic Cardiac Rhythm Disease Management | 2022-11-03 |
| Ventak® PRX Pulse Generator (P910077/S189) | Boston Scientific | 2022-11-02 |
| Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S088) | Boston Scientific | 2022-11-02 |
| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S564) | Boston Scientific Corp | 2022-11-02 |
| Imagerade MR Conditional Pacing System and Ingevity Pacing/Sense Lead (P150012/S135) | Boston Scientific | 2022-11-02 |
| Thinline Endocardial Pacing Leads (P960004/S101) | Boston Scientific | 2022-11-02 |
| Ventak® P2 System (P930035/S033) | Boston Scientific | 2022-11-02 |
| Sweet TIP® RX Steroid Eluting Lead (P960006/S055) | Boston Scientific | 2022-11-02 |
| Endotak Lead System (P910073/S170) | Boston Scientific | 2022-11-02 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S021) | Medtronic Vascular, Inc. | 2022-11-01 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Talent Endoluminal Occl (P100021/S108) | Medtronic Vascular | 2022-11-01 |
| Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting (P160043/S062) | Medtronic Vascular | 2022-11-01 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens (P100040/S053) | Medtronic Vascular | 2022-11-01 |
| Micra (P150033/S157) | Medtronic, Inc. | 2022-11-01 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S070) | Medtronic, Inc. | 2022-11-01 |
| Harmony Delivery Catheter System (P200046/S012) | Medtronic, Inc. | 2022-11-01 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst (P130021/S126) | Medtronic, Inc. | 2022-11-01 |
| Medtronic Evolut PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery Catheter System, Medtronic Evolut FX Deliv (P130021/S125) | Medtronic, Inc. | 2022-11-01 |
| Avive Automated External Defibrillator (AED) System (P210015) | Avive Solutions, Inc. | 2022-10-31 |
| HeartWare® Ventricular Assist System (P100047/S202) | Medtronic | 2022-10-31 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S099) | Abiomed, Inc. | 2022-10-28 |
| S-ICD GEN 2, S-ICD EMBLEM MRI (P110042/S175) | Boston Scientific Corporation | 2022-10-28 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S024) | Edwards Lifesciences, LLC | 2022-10-28 |
| Impella RP Flex with SmartAssist (P170011/S039) | Abiomed, Inc. | 2022-10-28 |
| PG ESSENTIO SR SL WW, PG ESSENTIO DR SL WW, PG ESSENTIO DR EL WW, PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPO (N970003/S279) | Boston Scientific Corp | 2022-10-28 |
| EXOSEAL® Vascular Closure Device (P100013/S026) | Cordis US Corporation | 2022-10-28 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S133) | Boston Scientific | 2022-10-28 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S054) | Boston Scientific Corp | 2022-10-28 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR (P010012/S562) | Boston Scientific Corp | 2022-10-28 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S486) | Boston Scientific | 2022-10-28 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S080) | St Jude Medical | 2022-10-28 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S224) | Guidant Corp. | 2022-10-28 |
| Impella RP Flex with SmartAssist and Impella RP with SmartAssist (P170011/S040) | Abiomed, Inc. | 2022-10-28 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S034) | Physio-Control, Inc. | 2022-10-27 |
| MynxGrip Vascular Closure Device and two components of Mynx Control Vascular Closure Device (VCD) (P040044/S093) | Cordis US Corporation | 2022-10-27 |
| TherOx Downstream Console (P170027/S010) | Zoll Circulation, Inc. | 2022-10-27 |
| Valiant Thoracic Stent Graft with Captivia delivery System (P100040/S052) | Medtronic Vascular | 2022-10-27 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S005) | Kestra Medical Technologies, Inc. | 2022-10-27 |
| Edwards Certitude Introducer Sheath Set (P140031/S147) | Edwards Lifesciences, LLC | 2022-10-26 |
| CapSureFix Novus Lead (P930039/S246) | Medtronic, Inc. | 2022-10-25 |
| CapSure Sense Lead (P830061/S209) | Medtronic Cardiac Rhythm Disease Management | 2022-10-25 |
| Sprint Quattro Lead (P920015/S272) | Medtronic, Inc. | 2022-10-25 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S732) | Medtronic, Inc. | 2022-10-25 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M (P980035/S731) | Medtronic, Inc. | 2022-10-25 |
| Assure Wearable Cardioverter Defibrillator (WCD) system (P200037/S004) | Kestra Medical Technologies, Inc. | 2022-10-25 |
| 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 (P010031/S806) | Medtronic Cardiac Rhythm Disease Management | 2022-10-25 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S840) | Medtronic Cardiac Rhythm Disease Management | 2022-10-25 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S509) | Medtronic, Inc. | 2022-10-25 |
| Edwards Commander Delivery System (P200015/S030) | Edwards Lifesciences, LLC | 2022-10-24 |
| Edwards Commander Delivery System (P140031/S148) | Edwards Lifesciences, LLC | 2022-10-24 |
| ELCA Coronary Laser Catheters (P910001/S117) | Spectranetics Corp. | 2022-10-21 |
| Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve AP360 (P990046/S065) | Medtronic Ats Medical, Inc. | 2022-10-21 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S022) | Terumo Medical Corporation | 2022-10-21 |
| 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 (P010031/S804) | Medtronic Cardiac Rhythm Disease Management | 2022-10-20 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P (P010015/S508) | Medtronic, Inc. | 2022-10-20 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S140) | Biotronik, Inc. | 2022-10-20 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, Mirro MRI DR/VR ICD (P980016/S838) | Medtronic Cardiac Rhythm Disease Management | 2022-10-20 |
| Permanent Defibrillator Electrodes (P980023/S115) | Biotronik, Inc. | 2022-10-20 |
| Drug Eluting Permanent Right Ventricular (RV), Right Atrial (RA) Pacemaker Electrodes (P950037/S239) | Biotronik, Inc. | 2022-10-20 |
| EDWARDS INTUITY Elite Valve System (P150036/S065) | Edwards Lifesciences, LLC | 2022-10-19 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S210) | Edwards Lifesciences, LLC | 2022-10-19 |
| PASCAL Precision Implant System (PASCAL Implant, 10mm), PASCAL Precision Implant System (PASCAL Ace Implant, 5mm) (P220003/S001) | Edwards Lifesciences, LLC | 2022-10-19 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S069) | Edwards Lifesciences, LLC | 2022-10-19 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S127) | Boston Scientific Corp | 2022-10-17 |
| Endurant Stent Graft System, Endurant II Stent Graft System (P100021/S106) | Medtronic Vascular | 2022-10-17 |
| ROTAWIRE Guidewire (P900056/S202) | Boston Scientific Corp | 2022-10-17 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN Left Atrial Appendage (LAA) Closure Te (P130013/S050) | Boston Scientific Corp | 2022-10-17 |
| MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S048) | ABBOTT MEDICAL | 2022-10-17 |
| CareLink SmartSync Platform, CareLink SmartSync MRI Host Application, CareLink SmartSync Common Application and Patient (P890003/S455) | Medtronic, Inc. | 2022-10-16 |
| Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S723) | Medtronic, Inc. | 2022-10-16 |
| Micra TPS, Micra AV TPS (P150033/S145) | Medtronic, Inc. | 2022-10-16 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S087) | ABBOTT MEDICAL | 2022-10-14 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S487) | Boston Scientific | 2022-10-14 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S049) | ABBOTT MEDICAL | 2022-10-14 |
| 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 (P010031/S803) | Medtronic Cardiac Rhythm Disease Management | 2022-10-14 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P (P010015/S507) | Medtronic, Inc. | 2022-10-14 |