| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S550) | Boston Scientific Corp | 2022-03-04 |
| CardioMEMS HF System (P100045/S060) | ABBOTT MEDICAL | 2022-03-04 |
| Ventak AV Acid VENTAK Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator System (P960040/S475) | Boston Scientific | 2022-03-04 |
| Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60 (P950037/S233) | Biotronik, Inc. | 2022-03-04 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S072) | St Jude Medical | 2022-03-04 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S153) | W. L. Gore & Associates, Inc. | 2022-03-03 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S092) | W. L. Gore & Associates, Inc. | 2022-03-03 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S703) | Medtronic, Inc. | 2022-03-02 |
| Sorint Quattro Lead (P920015/S265) | Medtronic, Inc. | 2022-03-02 |
| Cordis® Exoseal® Vascular Closure Device (P100013/S024) | Cordis US Corporation | 2022-03-01 |
| BioMimics 3D Vascular Stent System (P180003/S005) | Veryan Medical, Ltd. | 2022-03-01 |
| Melody Transcatheter Pulmonary Valve System (P140017/S021) | Medtronic, Inc. | 2022-03-01 |
| HeartWare Ventricular Assist System (P100047/S192) | Medtronic | 2022-03-01 |
| Avalus Bioprosthesis (P170006/S020) | Medtronic, Inc. | 2022-03-01 |
| Harmony Transcatheter Pulmonary Valve System (P200046/S007) | Medtronic, Inc. | 2022-03-01 |
| Evolut R Transcatheter Aortic Valve System, Evolut PRO Transcatheter Aortic Valve System, Evolut PRO+ Transcatheter Aort (P130021/S110) | Medtronic, Inc. | 2022-03-01 |
| AED Plus (P160015/S013) | ZOLL Medical Corporation | 2022-03-01 |
| Sprint Quattro Lead (P920015/S266) | Medtronic, Inc. | 2022-02-28 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S135) | Biotronik, Inc. | 2022-02-28 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M (P980035/S704) | Medtronic, Inc. | 2022-02-28 |
| CapSureFix Novus Lead (P930039/S239) | Medtronic, Inc. | 2022-02-28 |
| CapSure Sense Lead (P830061/S204) | Medtronic Cardiac Rhythm Disease Management | 2022-02-28 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S237) | Medtronic, Inc. | 2022-02-25 |
| 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/S807) | Medtronic Cardiac Rhythm Disease Management | 2022-02-25 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S020) | Cordis US Corporation | 2022-02-25 |
| Blazer II XP Catheter, Blazer Prime XP Catheter, IntellaTip MiFi XP Catheter, IntellaNav XP Catheter and IntellaNav MiFi (P020025/S135) | Boston Scientific | 2022-02-25 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S492) | Medtronic, Inc. | 2022-02-25 |
| Blazer II Catheter, Blazer II HTD Catheter, Blazer Prime HTD Catheter, and IntellaNav ST Catheter, Sterile Cables (P920047/S127) | Boston Scientific Corp | 2022-02-25 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S073) | Boston Scientific Corp | 2022-02-25 |
| Express SD Monorail Premounted Stent System (P060006/S103) | Boston Scientific Corp | 2022-02-25 |
| Micra AV TPS, Micra TPS (P150033/S135) | Medtronic, Inc. | 2022-02-25 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S013) | Boston Scientific Corporation | 2022-02-25 |
| 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/S705) | Medtronic, Inc. | 2022-02-25 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S045) | Cordis US Corporation | 2022-02-25 |
| Promus PREMIER and ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S202) | Boston Scientific Corp | 2022-02-25 |
| Micra AV TPS, Micra TPS (P150033/S134) | Medtronic, Inc. | 2022-02-25 |
| 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/S773) | Medtronic Cardiac Rhythm Disease Management | 2022-02-25 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S197) | Boston Scientific Corp | 2022-02-25 |
| SelectSecure Lead (P030036/S135) | Medtronic Cardiac Rhythm Disease Management | 2022-02-25 |
| Blazer Open Irrigated Catheter, IntellNav MiFi OI Catheter, IntellaNav OI Catheter, and IntellaTip MiFi OI Catheter, Ste (P150005/S070) | Boston Scientific Corp | 2022-02-25 |
| WOLVERINE Coronary Cutting Balloon (P950020/S116) | Boston Scientific Corp | 2022-02-25 |
| Chilli II Cooled Catheter, Sterile Cables, Tubing Kit (P980003/S093) | Boston Scientific Corp | 2022-02-25 |
| CRT-D Resynchronization Devices (P010012/S548) | Boston Scientific Corp | 2022-02-24 |
| Subcutaneous ICD Devices (P110042/S167) | Boston Scientific Corporation | 2022-02-24 |
| ELCA Coronary Atherectomy Catheters (P910001/S114) | Spectranetics Corp. | 2022-02-24 |
| CRT-P Resynchronization Devices (P030005/S215) | Guidant Corp. | 2022-02-24 |
| Pacemaker Devices (P150012/S120) | Boston Scientific | 2022-02-24 |
| Model 3300 LATITUDE Programming System (P910077/S187) | Boston Scientific | 2022-02-24 |
| Pacemaker Devices (N970003/S270) | Boston Scientific Corp | 2022-02-24 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIS Stent Graft System (P100021/S101) | Medtronic Vascular | 2022-02-24 |
| ICD Devices (P960040/S473) | Boston Scientific | 2022-02-24 |
| ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S021) | Biotronik AG | 2022-02-23 |
| Mosaic Bioprosthesis (P990064/S077) | Medtronic, Inc. | 2022-02-22 |
| GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S130) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder (P050006/S098) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| GORE® Excluder® Conformable AAA Endoprosthesis (P200030/S007) | W. L. Gore and Associates, Inc. | 2022-02-22 |
| IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter (P920047/S126) | Boston Scientific Corp | 2022-02-22 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S033) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S150) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| Freestyle Bioprosthesis (P970031/S064) | Medtronic, Inc. | 2022-02-22 |
| Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Tempera (P020025/S134) | Boston Scientific | 2022-02-22 |
| GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S187) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| Melody TPV (P140017/S013) | Medtronic, Inc. | 2022-02-22 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D (P010031/S771) | Medtronic Cardiac Rhythm Disease Management | 2022-02-22 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated (P150005/S069) | Boston Scientific Corp | 2022-02-22 |
| Hancock II Bioprosthesis (P980043/S069) | Medtronic, Inc. | 2022-02-22 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S089) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| Hancock Valved Conduit MO (P790007/S059) | Medtronic Heart Valves | 2022-02-22 |
| CoreValve TAV, Evolut-R TAV, Evolut PRO TAV (P130021/S056) | Medtronic, Inc. | 2022-02-22 |
| Avalus Bioprosthesis (P170006/S007) | Medtronic, Inc. | 2022-02-22 |
| Hancock Valved Conduit LP (P870078/S044) | Medtronic, Inc. | 2022-02-22 |
| GORE® VIATORR® TIPS Endoprosthesis (P040027/S090) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| Cobalt MRI ICD, Cobalt XT MRI ICD and Crome MRI ICD (P980016/S805) | Medtronic Cardiac Rhythm Disease Management | 2022-02-22 |
| Ranger Over-The-Wire Paclitaxel-Coated Balloon Catheter (P190019/S012) | Boston Scientific Corporation | 2022-02-22 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S056) | Edwards Lifesciences, LLC | 2022-02-22 |
| CardioMEMs HF System (P100045/S056) | ABBOTT MEDICAL | 2022-02-18 |
| ORSIRO Sirolimus Eluting Coronary Stent System, ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S019) | Biotronik AG | 2022-02-18 |
| Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter (P020045/S098) | Medtronic Cryocath, LP | 2022-02-18 |
| VenaSeal Closure System (P140018/S031) | Medtronic Vascular, Inc. | 2022-02-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S806) | Medtronic Cardiac Rhythm Disease Management | 2022-02-17 |
| 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/S772) | Medtronic Cardiac Rhythm Disease Management | 2022-02-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S042) | ABBOTT MEDICAL | 2022-02-16 |
| Patient Cable (P820003/S139) | Medtronic Cardiac Rhythm Disease Management | 2022-02-16 |
| Cordis® PRECISE® Nitinol Stent System (P030047/S043) | Cordis US Corporation | 2022-02-11 |
| Abre Venous Self-expanding Stent System (P200026/S004) | Medtronic Vascular, Inc. | 2022-02-11 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S188) | W. L. Gore & Associates, Inc. | 2022-02-11 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S011) | Bard Peripheral Vascular, Inc. | 2022-02-11 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S083) | Boston Scientific Corporation | 2022-02-10 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S038) | Medinol, Ltd. | 2022-02-10 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S200) | Boston Scientific Corp | 2022-02-10 |
| AngioJet Thrombectomy System (P980037/S087) | Boston Scientific Corp | 2022-02-09 |
| CoreValve Evolut R Delivery Catheter System, CoreValve Evolut Pro Delivery Catheter System, Evolut Pro+ Delivery Ca (P130021/S108) | Medtronic, Inc. | 2022-02-09 |
| Endurant II Stent Graft System, Endurant II Aort-Uni-Illac (AUI) Stent Graft System, Endurant IIs Stent Graft System, En (P100021/S100) | Medtronic Vascular | 2022-02-07 |
| Melody Transcatheter Pulmonary Valve (P140017/S020) | Medtronic, Inc. | 2022-02-02 |
| Zilver® PTX® Drug-Eluting Peripheral Stent (P100022/S040) | Cook Ireland, Ltd. | 2022-02-02 |
| ThermoCool SmartTouch (P030031/S125) | Biosense Webster, Inc. | 2022-02-01 |
| Micra AV TPS, Micra TPS (P150033/S133) | Medtronic, Inc. | 2022-02-01 |
| ThermoCool SmartTouch SF (P040036/S087) | Biosense Webster, Inc. | 2022-02-01 |
| 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/S768) | Medtronic Cardiac Rhythm Disease Management | 2022-01-31 |
| 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/S802) | Medtronic Cardiac Rhythm Disease Management | 2022-01-31 |