| HeartWare Ventricular Assist System (P100047/S186) | Medtronic | 2021-08-03 |
| GORE VIATORR TIPS Endoprosthesis product family (P040027/S086) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family (P130006/S082) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE EXCLUDER AAA Endoprosthesis product family (P020004/S179) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S029) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE TAG Thoracic Endoprosthesis product family (P040043/S123) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder (P050006/S091) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family (P040037/S143) | W. L. Gore & Associates, Inc. | 2021-08-02 |
| MitraClip NTR/XTR System, MitraClip G4System (P100009/S043) | ABBOTT MEDICAL | 2021-08-01 |
| OPTIMIZER Smart Mini System (P180036/S007) | Impulse Dynamics (Usa), Inc. | 2021-07-30 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S117) | Abbott Vascular | 2021-07-30 |
| Durata, Optisure (P950022/S140) | ABBOTT MEDICAL | 2021-07-29 |
| Open Pivot Aortic Valved Graft (P990046/S059) | Medtronic Ats Medical, Inc. | 2021-07-29 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S018) | Biotronik AG | 2021-07-28 |
| NuDEL Delivery System (P150028/S005) | NuMED, Inc. | 2021-07-28 |
| Amplatzer Muscular VSD Occluder (P040040/S044) | ABBOTT MEDICAL | 2021-07-27 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S050) | Medtronic Vascular | 2021-07-27 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S065) | ABBOTT MEDICAL | 2021-07-27 |
| Amplatzer Septal Occluder, Amplatzer Multi-Fenestrated Septal Occluder (P000039/S074) | ABBOTT MEDICAL | 2021-07-27 |
| PREVELEAK Surgical Sealant (P100030/S015) | Baxter Healthcare Corporation | 2021-07-27 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S031) | Spectranetics Corp. | 2021-07-27 |
| Amplatzer Patent Foramen Ovale (PFO) Occluder (P120021/S021) | ABBOTT MEDICAL | 2021-07-27 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037) | Kestra Medical Technologies, Inc. | 2021-07-27 |
| BioGlue Surgical Adhesive (P010003/S038) | Cryolife, Inc. | 2021-07-23 |
| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S055) | Edwards Lifesciences, LLC | 2021-07-23 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S467) | Boston Scientific | 2021-07-23 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S541) | Boston Scientific Corp | 2021-07-23 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, Compia MRI Quad CRT- (P010031/S752) | Medtronic Cardiac Rhythm Disease Management | 2021-07-22 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter (P200039/S003) | Shockwave Medical, Inc. | 2021-07-22 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S129) | Edwards Lifesciences, LLC | 2021-07-22 |
| HeartWare Ventricular Assist System (P100047/S185) | Medtronic | 2021-07-22 |
| Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( (P050023/S158) | Biotronik, Inc. | 2021-07-21 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S093) | Biotronik, Inc. | 2021-07-21 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S016) | Medtronic Vascular, Inc. | 2021-07-21 |
| Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR, (P950037/S226) | Biotronik, Inc. | 2021-07-21 |
| MetriQ Irrigation Tubing Set (P150005/S065) | Boston Scientific Corp | 2021-07-21 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S106) | Biotronik, Inc. | 2021-07-21 |
| 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/S127) | Biotronik, Inc. | 2021-07-21 |
| IntellaNav MiFi Open-Irrigated Ablation Catheters, IntellaTip MiFi Open-Irrigated Ablation Catheters, IntellaNav Open-Ir (P150005/S064) | Boston Scientific Corp | 2021-07-20 |
| Medtronic CoreValve Evolut PRO System, Medtronic CoreValve Evolut PRO+ System (P130021/S101) | Medtronic, Inc. | 2021-07-19 |
| Harmony Transcatheter Pulmonary Valve System (P200046/S005) | Medtronic, Inc. | 2021-07-19 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S196) | Medtronic Cardiac Rhythm Disease Management | 2021-07-16 |
| Micra AV TPS, Micra TPS (P150033/S116) | Medtronic, Inc. | 2021-07-16 |
| Coseal Surgical Sealant (P030039/S026) | Baxter Bio Science | 2021-07-15 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S478) | Medtronic, Inc. | 2021-07-14 |
| 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/S687) | Medtronic, Inc. | 2021-07-14 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S063) | Boston Scientific Corp | 2021-07-14 |
| INGEVITY Passive Fixation leads (P150012/S113) | Boston Scientific | 2021-07-14 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S787) | Medtronic Cardiac Rhythm Disease Management | 2021-07-14 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S751) | Medtronic Cardiac Rhythm Disease Management | 2021-07-14 |
| Micra AV TPS, Micra TPS (P150033/S115) | Medtronic, Inc. | 2021-07-14 |
| Impella Left Ventricular Support Systems (P140003/S082) | Abiomed, Inc. | 2021-07-13 |
| Duett Sealing Device (P990037/S035) | Vascular Solutions, Inc. | 2021-07-13 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S017) | Biotronik AG | 2021-07-13 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S014) | Biotronik AG | 2021-07-13 |
| Impella Ventricular Support Systems (P140003/S083) | Abiomed, Inc. | 2021-07-13 |
| Impella Ventricular Support Systems (P140003/S081) | Abiomed, Inc. | 2021-07-13 |
| Impella RP System (P170011/S033) | Abiomed, Inc. | 2021-07-12 |
| Evolut PRO+ Delivery Catheter System (P130021/S100) | Medtronic, Inc. | 2021-07-12 |
| EZ Steer ThemoCool Nav Bi-Directional Electrophysiology Catheter, Navistar ThermoCool Catheter, Navistar RMT ThermoCool, (P040036/S083) | Biosense Webster, Inc. | 2021-07-09 |
| Celsius ThermoCool Electrophysiology Catheter, EZ Steer ThermoCool Bi-Directional Electrophysiology Catheter, EZ Steer T (P030031/S121) | Biosense Webster, Inc. | 2021-07-09 |
| Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D (P950005/S081) | Biosense Webster, Inc. | 2021-07-09 |
| Smartablate System Interface Cables (P990071/S050) | Biosense Webster, Inc. | 2021-07-09 |
| Impella RP System (P170011/S031) | Abiomed, Inc. | 2021-07-09 |
| Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-Directional and EZ STEER NAV DS Bi-Directional Diagnostic/Ablation Defl (P010068/S066) | Biosense Webster, Inc. | 2021-07-09 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S003) | Cook Medical Incorporated | 2021-07-09 |
| Abre Venous Self-expanding Stent System (P200026/S002) | Medtronic Vascular, Inc. | 2021-07-09 |
| Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar (P990025/S066) | Biosense Webster, Inc. | 2021-07-09 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist System (P140003/S078) | Abiomed, Inc. | 2021-07-09 |
| Micra AV TPS and Micra TPS (P150033/S114) | Medtronic, Inc. | 2021-07-09 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S015) | Physio-Control, Inc. | 2021-07-08 |
| Micra AV TPS and Micra TPS (P150033/S113) | Medtronic, Inc. | 2021-07-08 |
| Infant/Child Reduced Energy Defibrillation Electrodes (P160012/S003) | Physio-Control, Inc. | 2021-07-08 |
| Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Entrant, Gallant, Ellipse (MR Conditional) (P910023/S438) | ABBOTT MEDICAL | 2021-07-07 |
| 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/S686) | Medtronic, Inc. | 2021-07-07 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL (P880086/S320) | ABBOTT MEDICAL | 2021-07-07 |
| Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) (P950022/S139) | ABBOTT MEDICAL | 2021-07-07 |
| Microny (P970013/S088) | ABBOTT MEDICAL | 2021-07-07 |
| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S393) | ABBOTT MEDICAL | 2021-07-07 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S069) | ABBOTT MEDICAL | 2021-07-07 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MR Conditional) (P030035/S187) | ABBOTT MEDICAL | 2021-07-07 |
| IsoFlex Optim (P960030/S075) | ABBOTT MEDICAL | 2021-07-07 |
| Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) (P960013/S119) | ABBOTT MEDICAL | 2021-07-07 |
| Harmony TPV System (P200046/S004) | Medtronic, Inc. | 2021-07-07 |
| ROTAPRO Rotational Atherectomy System (P900056/S193) | Boston Scientific Corp | 2021-07-06 |
| Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Pri (P980016/S786) | Medtronic Cardiac Rhythm Disease Management | 2021-07-02 |
| Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D (P010031/S749) | Medtronic Cardiac Rhythm Disease Management | 2021-07-02 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus-E (P150003/S077) | Boston Scientific Corporation | 2021-07-02 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P110010/S196) | Boston Scientific Corp | 2021-07-02 |
| Micra AV TPS and Micra TPS (P150033/S112) | Medtronic, Inc. | 2021-07-01 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus- (P150003/S076) | Boston Scientific Corporation | 2021-07-01 |
| CardioMEMS HF System (P100045/S055) | ABBOTT MEDICAL | 2021-07-01 |
| EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System (P130021/S098) | Medtronic, Inc. | 2021-06-30 |
| Cobalt XT HF Quad CRT-D MRI SureScan, Coblat HF Quad CRT-D MRI SureScan, Cobalt HF CRT-D MRI SureScan, Crome HF QUad CRT (P010031/S742) | Medtronic Cardiac Rhythm Disease Management | 2021-06-29 |
| Edwards Commander Delivery System, Crimper (P200015/S010) | Edwards Lifesciences, LLC | 2021-06-29 |
| Cobalt XT DR ICD MRI SureScan, Cobalt DR ICD MRI SureScan, Crome DR ICD MRI SureScan, Cobalt XT VR ICD MRI SureScan, Cob (P980016/S780) | Medtronic Cardiac Rhythm Disease Management | 2021-06-29 |
| VICI VENOUS STENT System (P180013/S007) | Boston Scientific Corporation | 2021-06-29 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S319) | ABBOTT MEDICAL | 2021-06-28 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S067) | ABBOTT MEDICAL | 2021-06-28 |
| Microny family of Pacemakers (P970013/S087) | ABBOTT MEDICAL | 2021-06-28 |