| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S007) | Medtronic Vascular, Inc. | 2021-12-17 |
| 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/S799) | Medtronic Cardiac Rhythm Disease Management | 2021-12-17 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S097) | Medtronic Vascular | 2021-12-17 |
| EMBLEM subcutaneous implantable cardioverter defibrillation (S-ICD) Programmer, EMBLEM Pulse Generator (PG) (P110042/S164) | Boston Scientific Corporation | 2021-12-17 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S053) | Medtronic, Inc. | 2021-12-17 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S003) | Kestra Medical Technologies, Inc. | 2021-12-17 |
| Barostim NEO System, Barostim NEO2 System (P180050/S001) | Cvrx, Inc. | 2021-12-17 |
| 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/S765) | Medtronic Cardiac Rhythm Disease Management | 2021-12-17 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cor (P150003/S081) | Boston Scientific Corporation | 2021-12-17 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S167) | Medtronic, Inc. | 2021-12-17 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S011) | Edwards Lifesciences, LLC | 2021-12-16 |
| Venovo Venous Stent System (P180037/S008) | Bard Peripheral Vascular, Inc. | 2021-12-16 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt (P130021/S107) | Medtronic, Inc. | 2021-12-16 |
| Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S045) | ABBOTT MEDICAL | 2021-12-16 |
| Harmony Transcatheter Pulmonary Valve (P200046/S006) | Medtronic, Inc. | 2021-12-16 |
| Lutonix Drug Coated Balloon PTA Catheter (P170003/S024) | Lutonix | 2021-12-16 |
| Biocor, Biocor Supra, Epic, Epic Supra, Epic Plus, Epic Plus Supra (P040021/S048) | ABBOTT MEDICAL | 2021-12-16 |
| Portico Transcatheter Heart Valve (P190023/S004) | ABBOTT MEDICAL | 2021-12-16 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S080) | Boston Scientific Corporation | 2021-12-16 |
| Gore Excluder Conformable AAA Endoprosthesis (EXCC) (P200030/S006) | W. L. Gore and Associates, Inc. | 2021-12-16 |
| GORE®1 EXCLUDER® AAA Endoprosthesis (AAA), GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) (P020004/S186) | W. L. Gore & Associates, Inc. | 2021-12-16 |
| OPTIMIZER Smart Mini System (P180036/S011) | Impulse Dynamics (Usa), Inc. | 2021-12-16 |
| Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl (P100010/S118) | Medtronic Cryocath, LP | 2021-12-16 |
| Cordis® EXOSEAL® Vascular Closure Device (P100013/S023) | Cordis US Corporation | 2021-12-15 |
| Innova Vascular Self-Expanding Stent System (P140028/S072) | Boston Scientific Corporation | 2021-12-15 |
| Zenith® Dissection Endovascular System (P180001/S003) | William Cook Europe Aps | 2021-12-15 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S048) | Boston Scientific Corp | 2021-12-15 |
| Arctic Front Advance, Arctic Front Advance Pro (P100010/S122) | Medtronic Cryocath, LP | 2021-12-14 |
| Resolute Integrity RX and OTW Zotarolimus-Eluting Coronary Stent System (P110013/S113) | Medtronic Vascular | 2021-12-14 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW (P160043/S049) | Medtronic Vascular | 2021-12-14 |
| Integrity Coronary Stent System RX and OTW (P030009/S105) | Medtronic, Ireland | 2021-12-14 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S263) | Medtronic, Inc. | 2021-12-13 |
| G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent (P150028/S006) | NuMED, Inc. | 2021-12-13 |
| MynxGrip Vascular Closure Device (SF, 6F/7F), Mynx Control Vascular Closure Device (SF, 6F/7F) (P040044/S090) | Cordis US Corporation | 2021-12-13 |
| SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex (P210014) | Advanced Bifurcation Systems, Inc. | 2021-12-13 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprostheses (P860057/S202) | Edwards Lifesciences, LLC | 2021-12-13 |
| Portico TAVI System (P190023/S003) | ABBOTT MEDICAL | 2021-12-13 |
| Valiant Captivia Stent Graft ith the Captivia Delivery System (P100040/S050) | Medtronic Vascular | 2021-12-10 |
| IntellaTip MiFi OI, IntellaNav MiFi OI, IntellaNav OI, Blazer OI (P150005/S068) | Boston Scientific Corp | 2021-12-10 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S033) | Boston Scientific Corp | 2021-12-10 |
| IN.PACT® AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S017) | Medtronic Vascular, Inc. | 2021-12-09 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S697) | Medtronic, Inc. | 2021-12-09 |
| IN.PACT® Admiral® Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S063) | Medtronic, Inc. | 2021-12-09 |
| Amplatzer Amulet LAA Occluder (P200049/S002) | ABBOTT MEDICAL | 2021-12-09 |
| Micra AV TPS, Micra TPS (P150033/S129) | Medtronic, Inc. | 2021-12-09 |
| Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) (P810002/S115) | ABBOTT MEDICAL | 2021-12-09 |
| NEO 2101.U (P000009/S092) | Biotronik, Inc. | 2021-12-09 |
| NEO 2101.U (P950037/S225) | Biotronik, Inc. | 2021-12-09 |
| 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/S766) | Medtronic Cardiac Rhythm Disease Management | 2021-12-09 |
| ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S020) | Biotronik AG | 2021-12-09 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S487) | Medtronic, Inc. | 2021-12-09 |
| BioGlue® Surgical Adhesive (P010003/S039) | Cryolife, Inc. | 2021-12-09 |
| 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/S800) | Medtronic Cardiac Rhythm Disease Management | 2021-12-09 |
| VenaSeal Closure System (P140018/S030) | Medtronic Vascular, Inc. | 2021-12-09 |
| NEO 2101.U (P050023/S157) | Biotronik, Inc. | 2021-12-09 |
| Preveleak Surgical Sealant, Preveleak Delivery Tips - 1O pack (P100030/S016) | Baxter Healthcare Corporation | 2021-12-09 |
| TherOx DownStream System (P170027/S006) | Zoll Circulation, Inc. | 2021-12-09 |
| NEO 2101.U (P070008/S126) | Biotronik, Inc. | 2021-12-09 |
| XACT Carotid Stent System (P040038/S039) | Abbott Vascular, Inc. | 2021-12-08 |
| Tendril STS Pacing Leads (P960013/S118) | ABBOTT MEDICAL | 2021-12-08 |
| RX Acculink Carotid Stent System (P040012/S063) | Abbott Vascular | 2021-12-08 |
| RX Herculink Elite Renal Stent System (P110001/S017) | Abbott Vascular | 2021-12-08 |
| CapSure Epicardial Pacing Lead (P950024/S101) | Medtronic, Inc. | 2021-12-07 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit, Vitatron Impulse II Lead (P850089/S159) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit, Vitatron Crystalline Lead (P830061/S200) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| ACE Header End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S167) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S486) | Medtronic, Inc. | 2021-12-07 |
| RF Conductr, RF Contactr, RF Enhancr II, RF Marinr, RF Unipolar Marinr (P930029/S070) | Medtronic, Inc. | 2021-12-07 |
| 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/S696) | Medtronic, Inc. | 2021-12-07 |
| 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/S798) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| CapSureFix MRI Lead (P090013/S317) | Medtronic, Inc. | 2021-12-07 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S165) | Medtronic, Inc. | 2021-12-07 |
| 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/S764) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Attain StarFix Lead (P060039/S109) | Medtronic, Inc. | 2021-12-07 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S133) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S261) | Medtronic, Inc. | 2021-12-07 |
| Micra AV TPS, Micra TPS (P150033/S127) | Medtronic, Inc. | 2021-12-07 |
| Myocardial Pacing Lead (P120017/S029) | Medtronic, Inc. | 2021-12-07 |
| Transvene CS/SVC Lead (P980050/S136) | Medtronic, Inc. | 2021-12-07 |
| CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S (P890003/S450) | Medtronic, Inc. | 2021-12-07 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S234) | Medtronic, Inc. | 2021-12-07 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S114) | Boston Scientific Corp | 2021-12-06 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S115) | Boston Scientific Corp | 2021-12-06 |
| GORE® VIABAHN® Endoprosthesis (P040037/S149) | W. L. Gore & Associates, Inc. | 2021-12-03 |
| LifeVest® Wearable Defibrillator (P010030/S156) | Zoll Manufacturing Corporation | 2021-12-03 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S088) | W. L. Gore & Associates, Inc. | 2021-12-03 |
| Lutonix 035 (P130024/S042) | Lutonix | 2021-12-02 |
| Lutonix 018 (P170003/S025) | Lutonix | 2021-12-02 |
| Medtronic CoreValve EnVeo R Delivery Catheter System, Medtronic CoreValve EnVeo Pro Delivery Catheter System, Medtro (P130021/S106) | Medtronic, Inc. | 2021-12-01 |
| Optisure (P950022/S142) | ABBOTT MEDICAL | 2021-12-01 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S695) | Medtronic, Inc. | 2021-11-30 |
| Subcutaneous ICD Devices (P110042/S159) | Boston Scientific Corporation | 2021-11-30 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S116) | Boston Scientific | 2021-11-30 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S267) | Boston Scientific Corp | 2021-11-30 |
| 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, E (P980016/S797) | Medtronic Cardiac Rhythm Disease Management | 2021-11-30 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S485) | Medtronic, Inc. | 2021-11-30 |
| LATITUDE Programming System (P910077/S186) | Boston Scientific | 2021-11-30 |
| 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/S763) | Medtronic Cardiac Rhythm Disease Management | 2021-11-30 |
| INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S212) | Guidant Corp. | 2021-11-30 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S468) | Boston Scientific | 2021-11-30 |