| Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System (P120002/S022) | Cordis US Corporation | 2022-12-07 |
| Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System (P020036/S047) | Cordis US Corporation | 2022-12-07 |
| IsoFlex (P960030/S077) | ABBOTT MEDICAL | 2022-12-07 |
| Assurity MRI, Endurity MRI (P140033/S076) | ABBOTT MEDICAL | 2022-12-07 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S176) | Boston Scientific Corporation | 2022-12-07 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S116) | Biotronik, Inc. | 2022-12-07 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S004) | Edwards Lifesciences, LLC | 2022-12-07 |
| Defibrillator, implantable, dual-chamber (P000009/S099) | Biotronik, Inc. | 2022-12-07 |
| AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set (P980037/S089) | Boston Scientific Corp | 2022-12-07 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S003) | Edwards Lifesciences, LLC | 2022-12-07 |
| Trifecta Valve with Glide Technology (P100029/S048) | ABBOTT MEDICAL | 2022-12-06 |
| AFX2 Endovascular AAA System (P040002/S070) | Endologix, LLC | 2022-12-06 |
| Impella RP, Impella RP with SmartAssist (P170011/S047) | Abiomed, Inc. | 2022-12-05 |
| OPTIMIZER SMART MINI, INTELIO Programmer, OPTIhome Remote Patient Monitoring System, Universal GUARDIO (P180036/S013) | Impulse Dynamics (Usa), Inc. | 2022-12-02 |
| DataBridge 4G/LTE Adapter (P950037/S240) | Biotronik, Inc. | 2022-12-02 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst (P130021/S128) | Medtronic, Inc. | 2022-12-01 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S111) | Medtronic Vascular | 2022-12-01 |
| Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin (P160043/S064) | Medtronic Vascular | 2022-12-01 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S071) | Medtronic, Inc. | 2022-12-01 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens (P100040/S055) | Medtronic Vascular | 2022-12-01 |
| Harmony Delivery Catheter System (P200046/S013) | Medtronic, Inc. | 2022-12-01 |
| Medtronic CoreValve Evolut FX System (P130021/S129) | Medtronic, Inc. | 2022-12-01 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S022) | Medtronic Vascular, Inc. | 2022-12-01 |
| VenaSeal Closure System (P140018/S036) | Medtronic Vascular, Inc. | 2022-12-01 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System, Endurant II Aorto-Uni-Ilia (P100021/S109) | Medtronic Vascular | 2022-11-30 |
| Trifecta Valve with Glide Technology (P100029/S047) | ABBOTT MEDICAL | 2022-11-29 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S062) | Boston Scientific Scimed, Inc. | 2022-11-28 |
| SelectSecure Lead (P030036/S141) | Medtronic Cardiac Rhythm Disease Management | 2022-11-28 |
| Micra AV TPS, Micra TPS (P150033/S163) | Medtronic, Inc. | 2022-11-28 |
| Medtronic Melody Transcatheter Pulmonic Valve System (P140017/S023) | Medtronic, Inc. | 2022-11-28 |
| Endurant Stent Graft System, Endurant II Stent Graft System and Endurant II AUI Stent Graft System (P100021/S110) | Medtronic Vascular | 2022-11-28 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S130) | Boston Scientific Corp | 2022-11-28 |
| WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S061) | Boston Scientific Corporation | 2022-11-28 |
| Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resoulute Onyx Over The Wire Zotarolimus-Eluting (P160043/S063) | Medtronic Vascular | 2022-11-28 |
| WALLSTENT TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S071) | Boston Scientific Corp | 2022-11-28 |
| Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extension) with the Captivia Delivery System and Valiant Thoracic Sten (P100040/S054) | Medtronic Vascular | 2022-11-28 |
| Medtronic CoreValve0153 Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System and Med (P130021/S127) | Medtronic, Inc. | 2022-11-28 |
| Express® LD Iliac Premounted Stent System (P090003/S053) | Boston Scientific Corporation | 2022-11-28 |
| Carotid WALLSTENT Monorail Endoprosthesis System (P050019/S036) | Boston Scientific Corp | 2022-11-28 |
| Promus Everolimus-Eluting Platinum Chromium Coronary Stent Systems (P110010/S206) | Boston Scientific Corp | 2022-11-28 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Systems (P150003/S089) | Boston Scientific Corporation | 2022-11-28 |
| QDOT MICRO System (P210027) | Biosense Webster, Inc. | 2022-11-23 |
| HeartSine samaritan® Public Access Automated External Defibrillators and Accessories (P160008/S020) | Heartsine Technologies, Ltd. | 2022-11-23 |
| HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (P160008/S021) | Heartsine Technologies, Ltd. | 2022-11-23 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S017) | Boston Scientific Corporation | 2022-11-23 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S061) | Boston Scientific Scimed, Inc. | 2022-11-22 |
| CapSure Epicardial Pacing Lead (P950024/S105) | Medtronic, Inc. | 2022-11-22 |
| SelectSecure Lead (P030036/S140) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S173) | Medtronic, Inc. | 2022-11-22 |
| HV Splitter/Adaptor Kit, Sprint Quattro Lead (P920015/S273) | Medtronic, Inc. | 2022-11-22 |
| 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/S734) | Medtronic, Inc. | 2022-11-22 |
| 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 VR ICD, (P980016/S841) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| 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/S808) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| CapSure SP Novus Lead, CapSure SP Z Lead and Vitatron Impulse II Lead (P850089/S163) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S735) | Medtronic, Inc. | 2022-11-22 |
| CapSure VDD-2 Lead and Vitatron Brilliant S+ VDD Lead (P890003/S458) | Medtronic, Inc. | 2022-11-22 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S247) | Medtronic, Inc. | 2022-11-22 |
| Supera Peripheral Stent System (P120020/S028) | Abbott Vascular (Idef Technologies Inc) | 2022-11-22 |
| CapSure Sense Lead and Vitatron Crysatlline Lead (P830061/S210) | Medtronic Cardiac Rhythm Disease Management | 2022-11-22 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S080) | Syncardia Systems, LLC | 2022-11-22 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S511) | Medtronic, Inc. | 2022-11-22 |
| Attain StarFix Lead (P060039/S112) | Medtronic, Inc. | 2022-11-22 |
| CapSureFix MRI Lead (P090013/S325) | Medtronic, Inc. | 2022-11-22 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S070) | Boston Scientific Corp | 2022-11-22 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S510) | Medtronic, Inc. | 2022-11-22 |
| Transvene CS/SVC Lead (P980050/S139) | Medtronic, Inc. | 2022-11-22 |
| Perceval Sutureless Heart Valve (P150011/S026) | Corcym S.r.l. | 2022-11-21 |
| Open-Irrigated Cardiac Ablation Catheters (P150005/S072) | Boston Scientific Corp | 2022-11-21 |
| MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System (P100009/S049) | ABBOTT MEDICAL | 2022-11-20 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S002) | Edwards Lifesciences, LLC | 2022-11-20 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S023) | Terumo Medical Corporation | 2022-11-18 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S733) | Medtronic, Inc. | 2022-11-18 |
| GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S193) | W. L. Gore & Associates, Inc. | 2022-11-18 |
| WOLVERINE Coronary Cutting Balloon (P950020/S131) | Boston Scientific Corp | 2022-11-17 |
| DIAMOND AF (P200028/S014) | Medtronic, Inc. | 2022-11-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories (P200015/S031) | Edwards Lifesciences, LLC | 2022-11-16 |
| Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses (P860057/S207) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S018) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S062) | Edwards Lifesciences, LLC | 2022-11-16 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S141) | Biotronik, Inc. | 2022-11-16 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S140) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards INTUITY Elite Valve System (P150036/S061) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories (P140031/S149) | Edwards Lifesciences, LLC | 2022-11-16 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S205) | Boston Scientific Corp | 2022-11-15 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S074) | Boston Scientific Corp | 2022-11-15 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S073) | Boston Scientific Corp | 2022-11-15 |
| Blazer II Cardiac Ablation System and Cable (P920047/S129) | Boston Scientific Corp | 2022-11-15 |
| WLOVERINE Coronary Cutting Balloon (P950020/S128) | Boston Scientific Corp | 2022-11-15 |
| Bi-Directional Torque Wrench Model 6628 (P960040/S482) | Boston Scientific | 2022-11-15 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S137) | Boston Scientific | 2022-11-15 |
| Express® SD Renal Monorail Premounted Stent System (P060006/S104) | Boston Scientific Corp | 2022-11-15 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S016) | Boston Scientific Corporation | 2022-11-15 |
| Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) (P040014/S046) | Irvine Biomedical, Inc. | 2022-11-15 |
| Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable (P040042/S052) | Irvine Biomedical,Inc.(Ibi) | 2022-11-15 |
| Chilli Cooled RF Ablation System (P980003/S094) | Boston Scientific Corp | 2022-11-15 |
| Bi-Directional Torque Wrench Model 6628 (P010012/S558) | Boston Scientific Corp | 2022-11-15 |
| AtriCure Synergy Ablation System (P100046/S013) | AtriCure, Inc. | 2022-11-15 |
| Micra AV TPS, Micra TPS (P150033/S159) | Medtronic, Inc. | 2022-11-15 |
| Rotablator Rotational Atherectomy System (P900056/S203) | Boston Scientific Corp | 2022-11-15 |
| OPTIMIZER Smart Mini System (P180036/S012) | Impulse Dynamics (Usa), Inc. | 2022-11-14 |