| Micra Transcatheter Pacing System, Micra AV TPS (P150033/S106) | Medtronic, Inc. | 2021-05-27 |
| CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (P010015/S470) | Medtronic, Inc. | 2021-05-27 |
| CareLink SmartSync Micra VR/AV Application (P150033/S096) | Medtronic, Inc. | 2021-05-27 |
| CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (P980035/S677) | Medtronic, Inc. | 2021-05-27 |
| CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (P980016/S775) | Medtronic Cardiac Rhythm Disease Management | 2021-05-27 |
| CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application (P010031/S737) | Medtronic Cardiac Rhythm Disease Management | 2021-05-27 |
| CapSureFix Novus Lead (P930039/S226) | Medtronic, Inc. | 2021-05-26 |
| INCRAFT AAA Stent Graft System (P150002/S010) | Cordis US Corporation | 2021-05-26 |
| DiamondTemp Radiofrequency (RF) Generator (P200028/S003) | Medtronic, Inc. | 2021-05-25 |
| HeartWare Ventricular Assist System (P100047/S179) | Medtronic | 2021-05-24 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S042) | Boston Scientific Corp | 2021-05-21 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S024) | Medinol, Ltd. | 2021-05-21 |
| TactiSys Quartz Equipment (P130026/S073) | St Jude Medical | 2021-05-21 |
| Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System (P110013/S111) | Medtronic Vascular | 2021-05-21 |
| Integrity Coronary Stent System Rx and OTW (P030009/S103) | Medtronic, Ireland | 2021-05-21 |
| IN.PACT AV DCB (P190008/S014) | Medtronic Vascular, Inc. | 2021-05-21 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S047) | Medtronic Vascular | 2021-05-21 |
| 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/S682) | Medtronic, Inc. | 2021-05-21 |
| IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S060) | Medtronic, Inc. | 2021-05-21 |
| Structural Heart Delivery Catheter Systems & Loading systems (P130021/S092) | Medtronic, Inc. | 2021-05-21 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S091) | Medtronic Vascular | 2021-05-21 |
| Valiant Navion Thoracic Stent Graft System, Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S047) | Medtronic Vascular | 2021-05-21 |
| Micra Transcatheter Pacemaker System, Micra Transcatheter Pacemaker System, Micra AV application software (P150033/S105) | Medtronic, Inc. | 2021-05-21 |
| Harmony Transcatheter Pulmonary System (P200046/S002) | Medtronic, Inc. | 2021-05-21 |
| Venaseal Closure System (P140018/S025) | Medtronic Vascular, Inc. | 2021-05-21 |
| DiamondTemp Ablation Catheters (P200028/S006) | Medtronic, Inc. | 2021-05-19 |
| X Series Advanced Devices (P160022/S028) | ZOLL Medical Corporation | 2021-05-19 |
| LifeStent Vascular Stent Systems (P070014/S060) | Bard Peripheral Vascular, Inc. | 2021-05-19 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S071) | St Jude Medical | 2021-05-18 |
| FlexAbility and FlexAbility SE Ablation Catheter (P110016/S076) | ABBOTT MEDICAL | 2021-05-18 |
| Therapy Cool Path (P060019/S053) | Irvine Biomedical, Inc. | 2021-05-18 |
| 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/S783) | Medtronic Cardiac Rhythm Disease Management | 2021-05-18 |
| 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/S745) | Medtronic Cardiac Rhythm Disease Management | 2021-05-18 |
| LiveWire TC Ablation Catheter and Safire Ablation Catheter (P960016/S087) | St Jude Medical | 2021-05-18 |
| 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/S681) | Medtronic, Inc. | 2021-05-18 |
| SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S075) | Boston Scientific Corporation | 2021-05-18 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S473) | Medtronic, Inc. | 2021-05-18 |
| LifeVest Wearable Defibrillator (P010030/S148) | Zoll Manufacturing Corporation | 2021-05-17 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S044) | Boston Scientific Corp | 2021-05-17 |
| LifeVest Wearable Defibrillator (P010030/S149) | Zoll Manufacturing Corporation | 2021-05-17 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S115) | Medtronic Cryocath, LP | 2021-05-13 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S125) | Edwards Lifesciences, LLC | 2021-05-13 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S113) | Abbott Vascular | 2021-05-13 |
| THERMOCOOL SMARTTOUCH SF Catheter (P030031/S118) | Biosense Webster, Inc. | 2021-05-13 |
| Supera Peripheral Stent System (P120020/S026) | Abbott Vascular (Idef Technologies Inc) | 2021-05-12 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S192) | Boston Scientific Corp | 2021-05-12 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S042) | Boston Scientific Corp | 2021-05-12 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems (P130021/S090) | Medtronic, Inc. | 2021-05-11 |
| Integrity Coronary Stent System (hereafter called Integrity) (P030009/S102) | Medtronic, Ireland | 2021-05-11 |
| ELCA Coronary Atherectomy Catheter (P910001/S113) | Spectranetics Corp. | 2021-05-11 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (hereafter called Resolute Onyx) (P160043/S046) | Medtronic Vascular | 2021-05-11 |
| Resolute Integrity Zotarolimus Eluting Coronary Stent Systems (hereafter called Resolute Integrity) (P110013/S110) | Medtronic Vascular | 2021-05-11 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S538) | Boston Scientific Corp | 2021-05-10 |
| VENTAK(R) P2 SYSTEM (P930035/S032) | Boston Scientific | 2021-05-10 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S111) | Boston Scientific | 2021-05-10 |
| THINLINE ENDOCARDIAL PACING LEADS (P960004/S094) | Boston Scientific | 2021-05-10 |
| VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P830060/S086) | Boston Scientific | 2021-05-10 |
| VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR (P910077/S184) | Boston Scientific | 2021-05-10 |
| SWEET TIP(R) RX STEROID ELUTING LEAD (P960006/S052) | Boston Scientific | 2021-05-10 |
| ENDOTAK LEAD SYSTEM (P910073/S161) | Boston Scientific | 2021-05-10 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S264) | Boston Scientific Corp | 2021-05-10 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S032) | Medtronic Vascular, Inc. | 2021-05-07 |
| Protégé RX Self-expanding Stent System, Protégé GPS Self-Expanding Peripheral Stent System (P060001/S032) | Medtronic Vascular, Inc. | 2021-05-07 |
| lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System (P030045/S006) | Medtronic Vascular, Inc. | 2021-05-07 |
| Abre Venous Self-expanding Stent System (P200026/S001) | Medtronic Vascular, Inc. | 2021-05-07 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CR T-D (P010031/S744) | Medtronic Cardiac Rhythm Disease Management | 2021-05-06 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S016) | Biotronik AG | 2021-05-06 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR (P150012/S110) | Boston Scientific | 2021-05-06 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S782) | Medtronic Cardiac Rhythm Disease Management | 2021-05-06 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S013) | Biotronik AG | 2021-05-06 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S464) | Boston Scientific | 2021-05-06 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S209) | Guidant Corp. | 2021-05-06 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S263) | Boston Scientific Corp | 2021-05-06 |
| Astron Peripheral Self- Expanding Nitinol Stent System (P140030/S013) | Biotronik AG | 2021-05-06 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D (P010012/S537) | Boston Scientific Corp | 2021-05-06 |
| Astron Pulsar Stent System (P160025/S011) | Biotronik AG | 2021-05-06 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, (P980016/S774) | Medtronic Cardiac Rhythm Disease Management | 2021-05-05 |
| Micra AV TPS and Micra TPS (P150033/S095) | Medtronic, Inc. | 2021-05-05 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S469) | Medtronic, Inc. | 2021-05-05 |
| ENROUTE® Transcarotid Stent System (P140026/S018) | Boston Scientific Corporation | 2021-05-05 |
| 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/S736) | Medtronic Cardiac Rhythm Disease Management | 2021-05-05 |
| MyCareLink Patient Monitor (P890003/S443) | Medtronic, Inc. | 2021-05-05 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S676) | Medtronic, Inc. | 2021-05-05 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S128) | W. L. Gore & Associates, Inc. | 2021-05-04 |
| Conformable GORE TAG Thoracic Endoprosthesis (P040043/S127) | W. L. Gore & Associates, Inc. | 2021-05-04 |
| Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter (P110016/S075) | ABBOTT MEDICAL | 2021-05-04 |
| Therapy Cool Path Ablation Catheter (P060019/S052) | Irvine Biomedical, Inc. | 2021-05-04 |
| Therapy Ablation Catheter, Therapy 4MM Thermistor Ablation Catheter, Therapy Bi-Directional Ablation Catheter (P040014/S044) | Irvine Biomedical, Inc. | 2021-05-04 |
| Safire TX Ablation Catheter, Therapy Dual 8 Ablation Catheter, Therapy 8MM Thermistor Ablation Catheter (P040042/S050) | Irvine Biomedical,Inc.(Ibi) | 2021-05-04 |
| Express LD Iliac Premounted Stent System (P090003/S051) | Boston Scientific Corporation | 2021-04-30 |
| SICD Gen 2, SICD MRI (P110042/S156) | Boston Scientific Corporation | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P980023/S105) | Biotronik, Inc. | 2021-04-30 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D (P010012/S536) | Boston Scientific Corp | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P050023/S154) | Biotronik, Inc. | 2021-04-30 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR (P150012/S109) | Boston Scientific | 2021-04-30 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S463) | Boston Scientific | 2021-04-30 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S262) | Boston Scientific Corp | 2021-04-30 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S208) | Guidant Corp. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P000009/S090) | Biotronik, Inc. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P950037/S220) | Biotronik, Inc. | 2021-04-30 |