| Pulse Generator, Permanent, Implantable (P950037/S236) | Biotronik, Inc. | 2022-06-21 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-DP) (P070008/S137) | Biotronik, Inc. | 2022-06-21 |
| ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/IS1, ICD INOGEN CRT-D DF1/IS1/IS4, ICD INOGEN CRT-D DF4/IS1/IS4, ICD D (P010012/S554) | Boston Scientific Corp | 2022-06-21 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S064) | Medtronic, Inc. | 2022-06-21 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S114) | Biotronik, Inc. | 2022-06-21 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def (P050023/S167) | Biotronik, Inc. | 2022-06-21 |
| Defibrillator, Implantable, dual-chamber (P000009/S098) | Biotronik, Inc. | 2022-06-21 |
| Thoraflex Hybrid (P210006/S002) | Vascutek, Ltd. | 2022-06-16 |
| ConMed PadPro Multifunction Electrodes (P200004/S001) | Conmed Corporation | 2022-06-16 |
| HeartWare Ventricular Assist System (P100047/S198) | Medtronic | 2022-06-16 |
| Impella RP, Impella RP with Smart Assist (P170011/S041) | Abiomed, Inc. | 2022-06-16 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with Smart Assist (P140003/S100) | Abiomed, Inc. | 2022-06-16 |
| DiamondTemp Ablation Catheters (P200028/S011) | Medtronic, Inc. | 2022-06-15 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S026) | Berlin Heart, Inc. | 2022-06-15 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System (P160043/S061) | Medtronic Vascular | 2022-06-15 |
| Barostim System (P180050/S006) | Cvrx, Inc. | 2022-06-14 |
| SmartAblate Irrigation Tubing Set and nGEN Pump (P990071/S054) | Biosense Webster, Inc. | 2022-06-08 |
| HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator (P160029/S016) | Philips Medical Systems, Inc. | 2022-06-08 |
| Medtronic Evolut FX Delivery Catheter System (P130021/S117) | Medtronic, Inc. | 2022-06-08 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S034) | Medtronic Vascular, Inc. | 2022-06-07 |
| 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 (P980035/S720) | Medtronic, Inc. | 2022-06-07 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent System with Entrust Delivery S (P110023/S035) | Medtronic Vascular, Inc. | 2022-06-03 |
| Protégé GPS Self Expanding Peripheral Stent System (P060001/S034) | Medtronic Vascular, Inc. | 2022-06-03 |
| Zenith Dissection Endovascular System (P180001/S005) | William Cook Europe Aps | 2022-06-02 |
| Arctic Front Advance, Arctic Front Advance Pro (P100010/S128) | Medtronic Cryocath, LP | 2022-06-01 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead A (P920015/S269) | Medtronic, Inc. | 2022-06-01 |
| CapSureFix MRI Lead (P090013/S322) | Medtronic, Inc. | 2022-06-01 |
| Micra AV TPS, Micra TPS (P150033/S141) | Medtronic, Inc. | 2022-06-01 |
| Attain StarFix Lead (P060039/S111) | Medtronic, Inc. | 2022-06-01 |
| Attain Bipolar OTW Lead,Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena B (P010015/S500) | Medtronic, Inc. | 2022-06-01 |
| Myocardial Pacing Lead (P120017/S031) | Medtronic, Inc. | 2022-06-01 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S138) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S162) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S501) | Medtronic, Inc. | 2022-06-01 |
| Transvene CS/SVC Lead (P980050/S138) | Medtronic, Inc. | 2022-06-01 |
| CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S (P890003/S454) | Medtronic, Inc. | 2022-06-01 |
| LifeVest Wearable Defibrillator (P010030/S159) | Zoll Manufacturing Corporation | 2022-06-01 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S172) | Medtronic, Inc. | 2022-06-01 |
| ACE Header, End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S169) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S243) | Medtronic, Inc. | 2022-06-01 |
| 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/S823) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| Adapta, Versa, Sensia IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta DR/SR MRI IPG, Azure S DR/SR MRI IPG, (P980035/S719) | Medtronic, Inc. | 2022-06-01 |
| CapSure Epicardial Pacing Lead (P950024/S104) | Medtronic, Inc. | 2022-06-01 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S207) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| 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/S718) | Medtronic, Inc. | 2022-06-01 |
| RF Conductr, RF Enhancr II, RF Marinr, RF Unipolar Marinr (P930029/S071) | Medtronic, Inc. | 2022-06-01 |
| 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/S790) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| HeartSine samaritan® Public Access Automated External Defibrillators and Accessories (P160008/S019) | Heartsine Technologies, Ltd. | 2022-05-31 |
| AED Plus (P160015/S014) | ZOLL Medical Corporation | 2022-05-27 |
| 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, Ev (P980016/S820) | Medtronic Cardiac Rhythm Disease Management | 2022-05-26 |
| GORE VIABAHN Endoprosthesis (P040037/S152) | W. L. Gore & Associates, Inc. | 2022-05-26 |
| Bard E- Luminexx Vascular Stent System (P080007/S027) | Bard Peripheral Vascular, Inc. | 2022-05-26 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S091) | W. L. Gore & Associates, Inc. | 2022-05-26 |
| 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/S787) | Medtronic Cardiac Rhythm Disease Management | 2022-05-26 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S821) | Medtronic Cardiac Rhythm Disease Management | 2022-05-25 |
| SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chro (P150003/S086) | Boston Scientific Corporation | 2022-05-25 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S788) | Medtronic Cardiac Rhythm Disease Management | 2022-05-25 |
| BioGlue Surgical Adhesive (P010003/S040) | Cryolife, Inc. | 2022-05-25 |
| Tack Endovascular System (4F) (P190027/S004) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2022-05-24 |
| Tack Endovascular System (6F) (P180034/S007) | Philips Image Guided Therapy Corporation | 2022-05-24 |
| Harmony Transcatheter Pulmonary Valve (P200046/S009) | Medtronic, Inc. | 2022-05-23 |
| Venovo Venous Stent System (P180037/S011) | Bard Peripheral Vascular, Inc. | 2022-05-23 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt (P130021/S116) | Medtronic, Inc. | 2022-05-23 |
| Protege RX Carotid Stent System (P060001/S033) | Medtronic Vascular, Inc. | 2022-05-23 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S822) | Medtronic Cardiac Rhythm Disease Management | 2022-05-20 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S789) | Medtronic Cardiac Rhythm Disease Management | 2022-05-20 |
| Pulsar-18 Stent Systems (P160025/S014) | Biotronik AG | 2022-05-20 |
| Venovo Venous Stent System (P180037/S010) | Bard Peripheral Vascular, Inc. | 2022-05-20 |
| WOLVERINE Coronary Cutting Balloon (P950020/S121) | Boston Scientific Corp | 2022-05-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cono (P150003/S087) | Boston Scientific Corporation | 2022-05-19 |
| AngelMed Guardian System (P150009/S007) | Avertix Medical, Inc. | 2022-05-19 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S048) | Boston Scientific Corp | 2022-05-19 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S169) | Boston Scientific Corporation | 2022-05-18 |
| HeartWare Ventricular Assist System (P100047/S184) | Medtronic | 2022-05-18 |
| Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avant VR, Avant DR (P910023/S444) | ABBOTT MEDICAL | 2022-05-18 |
| Microny family of Pacemakers (P970013/S090) | ABBOTT MEDICAL | 2022-05-17 |
| 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/S786) | Medtronic Cardiac Rhythm Disease Management | 2022-05-17 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D (P980035/S717) | Medtronic, Inc. | 2022-05-17 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S499) | Medtronic, Inc. | 2022-05-17 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S443) | ABBOTT MEDICAL | 2022-05-17 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S323) | ABBOTT MEDICAL | 2022-05-17 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S072) | ABBOTT MEDICAL | 2022-05-17 |
| Micra AV TPS and Micra TPS (P150033/S140) | Medtronic, Inc. | 2022-05-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I (P980016/S819) | Medtronic Cardiac Rhythm Disease Management | 2022-05-17 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S189) | ABBOTT MEDICAL | 2022-05-17 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S398) | ABBOTT MEDICAL | 2022-05-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I (P980016/S818) | Medtronic Cardiac Rhythm Disease Management | 2022-05-16 |
| 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/S785) | Medtronic Cardiac Rhythm Disease Management | 2022-05-16 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System (P100021/S104) | Medtronic Vascular | 2022-05-13 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032) | W. L. Gore & Associates, Inc. | 2022-05-13 |
| Zilver® PTX® Drug-Eluting Peripheral Stent (P100022/S039) | Cook Ireland, Ltd. | 2022-05-13 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System (P160043/S055) | Medtronic Vascular | 2022-05-12 |
| CapSureFix MRI Lead (P090013/S321) | Medtronic, Inc. | 2022-05-11 |
| CentriMag Circulatory Support System (P170038/S010) | Abbott | 2022-05-11 |
| CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S242) | Medtronic, Inc. | 2022-05-11 |
| 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 (P980035/S715) | Medtronic, Inc. | 2022-05-10 |
| HeartWare® Ventricular Assist System (P100047/S197) | Medtronic | 2022-05-10 |
| GORE CARDIOFORM Septal Occluder (P050006/S099) | W. L. Gore & Associates, Inc. | 2022-05-09 |
| HeartStart Onsite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P (P160029/S014) | Philips Medical Systems, Inc. | 2022-05-09 |
| lnnova Vascular Self-Expanding Stent with Delivery System (P140028/S073) | Boston Scientific Corporation | 2022-05-06 |