| PSW 2100.U and NEO 2100.U (P070008/S122) | Biotronik, Inc. | 2021-04-30 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt (P130021/S091) | Medtronic, Inc. | 2021-04-29 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems (P130021/S093) | Medtronic, Inc. | 2021-04-29 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S073) | Boston Scientific Corporation | 2021-04-29 |
| Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter (P990025/S063) | Biosense Webster, Inc. | 2021-04-28 |
| EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca (P040036/S080) | Biosense Webster, Inc. | 2021-04-28 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S036) | ABBOTT MEDICAL | 2021-04-28 |
| Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, (P950005/S078) | Biosense Webster, Inc. | 2021-04-28 |
| EPi-Sense Guided Coagulation System (P200002) | AtriCure, Inc. | 2021-04-28 |
| Biosense Webster Cables (P990071/S048) | Biosense Webster, Inc. | 2021-04-28 |
| Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (P030031/S116) | Biosense Webster, Inc. | 2021-04-28 |
| Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT (P010068/S063) | Biosense Webster, Inc. | 2021-04-28 |
| ACUITY X4 Quadripolar Coronary Venous Pace/Sense Leads (P010012/S534) | Boston Scientific Corp | 2021-04-28 |
| EZ STEERDS, EZ STEERNAV, EZ STEER, EZ STEERTHERMOCOOL NAV (P030031/S117) | Biosense Webster, Inc. | 2021-04-27 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S002) | Cook Medical Incorporated | 2021-04-27 |
| NAVISTARRMT THERMOCOOL, NAVISTARDS, EZ STEERNAV DS (P990025/S064) | Biosense Webster, Inc. | 2021-04-27 |
| RMT THERMOCOOL, NAVISTAR, NAVISTARRMT, NAVISTARTHERMOCOOL (P010068/S064) | Biosense Webster, Inc. | 2021-04-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S059) | Medtronic, Inc. | 2021-04-27 |
| CapSureFix Novus Lead (P930039/S225) | Medtronic, Inc. | 2021-04-27 |
| EZ STEERTHERMOCOOL, THERMOCOOLSF NAV, THERMOCOOLSF (P040036/S081) | Biosense Webster, Inc. | 2021-04-27 |
| LIFEPAK® 1000 Defibrillator (P160026/S025) | Physio-Control, Inc. | 2021-04-27 |
| CELSIUS, CELSIUSDS, CELSIUSRMT, CELSIUSTHERMOCOOL, CELSIUS (P950005/S079) | Biosense Webster, Inc. | 2021-04-27 |
| THERMOCOOLSMARTTOUCH, THERMOCOOLSMARTTOUCH SF (P990071/S049) | Biosense Webster, Inc. | 2021-04-27 |
| LifeVest Wearable Defibrillator (P010030/S147) | Zoll Manufacturing Corporation | 2021-04-26 |
| Astron Pulsar Stent System and Pulsar-18 Stent System (P160025/S010) | Biotronik AG | 2021-04-23 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S033) | Cardiovascular Systems, Inc. | 2021-04-23 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S012) | Biotronik AG | 2021-04-23 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S015) | Biotronik AG | 2021-04-23 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S012) | Biotronik AG | 2021-04-23 |
| CardioMEMS I3 Patient Electronics System (PES) (P100045/S051) | ABBOTT MEDICAL | 2021-04-22 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S191) | Boston Scientific Corp | 2021-04-22 |
| Open Pivot Heart Valves and Open Pivot Aortic Valved Graft (P990046/S058) | Medtronic Ats Medical, Inc. | 2021-04-22 |
| LIFEPAK Automated External Defibrillator (AED) (P160026/S023) | Physio-Control, Inc. | 2021-04-22 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S008) | Boston Scientific Corporation | 2021-04-20 |
| MANTA Vascular Closure Device (P180025/S009) | Teleflex Medical, LLC | 2021-04-19 |
| HeartStart Home Defibrillator and HeartStart Onsite Defibrillator (P160029/S011) | Philips Medical Systems, Inc. | 2021-04-19 |
| TREO Abdominal Stent-Graft System (P190015/S009) | Bolton Medical, Inc. | 2021-04-19 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI D (P980016/S768) | Medtronic Cardiac Rhythm Disease Management | 2021-04-16 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S781) | Medtronic Cardiac Rhythm Disease Management | 2021-04-16 |
| 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/S730) | Medtronic Cardiac Rhythm Disease Management | 2021-04-16 |
| 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, Compia (P010031/S743) | Medtronic Cardiac Rhythm Disease Management | 2021-04-16 |
| Implantable Pulse Generator Test Magnet (P830060/S084) | Boston Scientific | 2021-04-16 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S035) | Medinol, Ltd. | 2021-04-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S009) | Edwards Lifesciences, LLC | 2021-04-16 |
| Endurant, Endurant II and Endurant IIs Stent Graft System, Talent Occluder with Occluder Delivery System (P100021/S090) | Medtronic Vascular | 2021-04-15 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S144) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S083) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S087) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S126) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| BioMimics 3D Vascular Stent System (P180003/S004) | Veryan Medical, Ltd. | 2021-04-15 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System (P100040/S046) | Medtronic Vascular | 2021-04-15 |
| GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder (P050006/S092) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (P020004/S181) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| Micra Transcatheter Pacing System (TPS) (P150033/S101) | Medtronic, Inc. | 2021-04-15 |
| GORE EXCLUDER Conformable AAA Endoprosthesis (P200030/S002) | W. L. Gore and Associates, Inc. | 2021-04-15 |
| RESILIA Solutions System (P150048/S053) | Edwards Lifesciences, LLC | 2021-04-15 |
| Micra AV TPS and Micra TPS (P150033/S100) | Medtronic, Inc. | 2021-04-14 |
| Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis SR, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, (P950037/S221) | Biotronik, Inc. | 2021-04-14 |
| Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni (P070008/S123) | Biotronik, Inc. | 2021-04-14 |
| 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/S779) | Medtronic Cardiac Rhythm Disease Management | 2021-04-12 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG. Astra XT DR/SR MRI IPG, Attesta D (P980035/S679) | Medtronic, Inc. | 2021-04-12 |
| 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/S741) | Medtronic Cardiac Rhythm Disease Management | 2021-04-12 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Biplar CRT-P, Serena Quadripolar CRT-P, Solar (P010015/S472) | Medtronic, Inc. | 2021-04-12 |
| Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional) (P910023/S436) | ABBOTT MEDICAL | 2021-04-09 |
| Microny (P970013/S086) | ABBOTT MEDICAL | 2021-04-09 |
| Tendril ST Lead, OptiSense, Tendril STS Lead and Tendril STS Lead (MR Conditional) (P960013/S117) | ABBOTT MEDICAL | 2021-04-09 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S001) | Shockwave Medical, Inc. | 2021-04-09 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL and Verity ADx XL (P880086/S318) | ABBOTT MEDICAL | 2021-04-09 |
| Durata, Durata (MR Conditional), Optisure and Optisure (MR Conditional) (P950022/S138) | ABBOTT MEDICAL | 2021-04-09 |
| ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S535) | Boston Scientific Corp | 2021-04-09 |
| Allure, Allure Quadra, Quadra Allure MP and Quadra Allure (MRI Conditional) (P030035/S185) | ABBOTT MEDICAL | 2021-04-09 |
| Assurity MRI, Endurity MRI and Tendril MRI (P140033/S066) | ABBOTT MEDICAL | 2021-04-09 |
| IsoFlex Optim (P960030/S074) | ABBOTT MEDICAL | 2021-04-09 |
| Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S391) | ABBOTT MEDICAL | 2021-04-09 |
| IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable (P020025/S130) | Boston Scientific | 2021-04-08 |
| AFX Endovascular AAA System (AFX System) (P040002/S067) | Endologix, LLC | 2021-04-08 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S740) | Medtronic Cardiac Rhythm Disease Management | 2021-04-08 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S125) | W. L. Gore & Associates, Inc. | 2021-04-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S778) | Medtronic Cardiac Rhythm Disease Management | 2021-04-08 |
| Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non (P030031/S114) | Biosense Webster, Inc. | 2021-04-07 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S034) | Medinol, Ltd. | 2021-04-07 |
| Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non (P030031/S115) | Biosense Webster, Inc. | 2021-04-07 |
| Celsius, Celsius RMT, EZ Steer Bi-directional non nav (P950005/S077) | Biosense Webster, Inc. | 2021-04-07 |
| Navistar Thermocool, EZ Steer Thermocool Nav Bi- Directional, Navistar RMT Thermocool, Thermocool SF Nav Bi-directional, (P040036/S079) | Biosense Webster, Inc. | 2021-04-07 |
| Navistar DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona (P010068/S062) | Biosense Webster, Inc. | 2021-04-07 |
| Epic Self-Expanding Nitinol Vascular Stent with Delivery System (P110035/S066) | Boston Scientific Corp | 2021-04-07 |
| Navistar, Navistar RMT, EZ Steer Nav Bi-directional (P990025/S062) | Biosense Webster, Inc. | 2021-04-07 |
| HeartLight X3 Endoscopic Ablation System (P150026/S012) | Cardiofocus, Inc. | 2021-04-06 |
| Harmony TPV System (P200046/S001) | Medtronic, Inc. | 2021-04-06 |
| HeartStart FRx Defibrillator (P180028/S005) | Philips Medical Systems | 2021-04-06 |
| Cardiomems HF System (P100045/S050) | ABBOTT MEDICAL | 2021-04-06 |
| HeartStart OnSite and Home Defibrillator (P160029/S008) | Philips Medical Systems, Inc. | 2021-04-06 |
| S-ICD, Q-TRAK Subcutaneous Electrode, Q-Tech Programmer and Related Accessories (P110042/S153) | Boston Scientific Corporation | 2021-04-02 |
| COSMOS System (P830026/S083) | Boston Scientific | 2021-04-02 |
| ACUITY Steerable Lead System (P050046/S031) | Guidant Corp. | 2021-04-02 |
| SELUTE Lead System (P950001/S029) | Boston Scientific | 2021-04-02 |
| INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S107) | Boston Scientific | 2021-04-02 |
| ENDOTAK Lead System (P910073/S160) | Boston Scientific | 2021-04-02 |
| Pulsar, Pulsar Max, Discovery, Nexus, Intelis, Insignia, Altrua, Advantio, Ingenio, Vitalio, Formio, Essentio, Proponent (N970003/S261) | Boston Scientific Corp | 2021-04-02 |
| Micra AV TPS, Micra TPS (P150033/S103) | Medtronic, Inc. | 2021-04-02 |