| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Azure S DR MR (P980035/S758) | Medtronic, Inc. | 2023-08-30 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S026) | Medtronic Vascular, Inc. | 2023-08-30 |
| Medtronic CoreValve TM EvolutTM R Transcatheter Aortic Valve, Medtronic CoreValveTM EvolutTM PRO Transcatheter Aortic V (P130021/S143) | Medtronic, Inc. | 2023-08-30 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, IN.PACT 018 Paclitaxel-C (P140010/S075) | Medtronic, Inc. | 2023-08-30 |
| MitraClip G4 Clip Delivery System (P100009/S057) | ABBOTT MEDICAL | 2023-08-30 |
| LifeVest® Wearable Defibrillator (P010030/S165) | Zoll Manufacturing Corporation | 2023-08-30 |
| GORE TAG Thoracic Branch Endoprosthesis (P210032/S011) | W. L. Gore & Associates, Inc. | 2023-08-30 |
| Rotablator, ROTAPRO Rotational Atherectomy System (P900056/S210) | Boston Scientific Corp | 2023-08-29 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S832) | Medtronic Cardiac Rhythm Disease Management | 2023-08-28 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S866) | Medtronic Cardiac Rhythm Disease Management | 2023-08-28 |
| Evolut FX Delivery Catheter System of the Medtronic Evolut FX System (P130021/S144) | Medtronic, Inc. | 2023-08-25 |
| ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S032) | Biotronik AG | 2023-08-25 |
| Edwards Crimper 9600CR (P140031/S163) | Edwards Lifesciences, LLC | 2023-08-25 |
| Edwards Crimper 9600CR (P200015/S045) | Edwards Lifesciences, LLC | 2023-08-25 |
| ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S031) | Biotronik AG | 2023-08-24 |
| Aveir VR and DR Leadless Pacemakers (P150035/S005) | ABBOTT MEDICAL | 2023-08-24 |
| MitraClip Clip Delivery System (P100009/S052) | ABBOTT MEDICAL | 2023-08-23 |
| ResQCPR System (P110024/S004) | ZOLL Medical Corporation | 2023-08-23 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S116) | Medtronic Vascular | 2023-08-23 |
| Medtronic Avalus Bioprosthesis (P170006/S023) | Medtronic, Inc. | 2023-08-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra (P200015/S044) | Edwards Lifesciences, LLC | 2023-08-22 |
| EXCOR Blood pump (P160035/S035) | Berlin Heart, Inc. | 2023-08-22 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S213) | Edwards Lifesciences, LLC | 2023-08-22 |
| EDWARDS INTUITY Elite Valve System (P150036/S070) | Edwards Lifesciences, LLC | 2023-08-22 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S074) | Edwards Lifesciences, LLC | 2023-08-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra (P140031/S161) | Edwards Lifesciences, LLC | 2023-08-22 |
| PSW 2302.U, NEO 2302.U (P950037/S250) | Biotronik, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P050023/S176) | Biotronik, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P070008/S150) | Biotronik, Inc. | 2023-08-21 |
| Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance PRO Cardiac Cryoablation Catheter (P100010/S139) | Medtronic Cryocath, LP | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P000009/S104) | Biotronik, Inc. | 2023-08-21 |
| HeartWare Ventricular Assist System or HeartWare System (P100047/S211) | Medtronic | 2023-08-20 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S009) | Kestra Medical Technologies, Inc. | 2023-08-17 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S005) | Shockwave Medical, Inc. | 2023-08-17 |
| Rotaglide Lubricant (P900056/S201) | Boston Scientific Corp | 2023-08-17 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S087) | St Jude Medical | 2023-08-17 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S097) | Boston Scientific Corporation | 2023-08-17 |
| FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled (P110016/S085) | ABBOTT MEDICAL | 2023-08-17 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S004) | ABBOTT MEDICAL | 2023-08-17 |
| LIFEPAK® 15 Defibrillator (P160026/S041) | Physio-Control, Inc. | 2023-08-16 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos (P950037/S251) | Biotronik, Inc. | 2023-08-16 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S003) | ABBOTT MEDICAL | 2023-08-16 |
| PRO-KINETIC ENERGY CORONARY STENT SYSTEM (P160003/S018) | Biotronik AG | 2023-08-16 |
| Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) (P210039/S001) | Trireme Medical, LLC | 2023-08-16 |
| GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis (P020004/S195) | W. L. Gore & Associates, Inc. | 2023-08-15 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S005) | ABBOTT MEDICAL | 2023-08-11 |
| HeartLight Catheter, HeartLight X3 Console V2 (P150026/S015) | Cardiofocus, Inc. | 2023-08-11 |
| Mosaic Bioprosthesis (P990064/S085) | Medtronic, Inc. | 2023-08-10 |
| Hancock II Bioprosthesis (P970031/S070) | Medtronic, Inc. | 2023-08-10 |
| Guardian System (P150009/S009) | Avertix Medical, Inc. | 2023-08-10 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S034) | Berlin Heart, Inc. | 2023-08-10 |
| Avalus Bioprosthesis (P170006/S022) | Medtronic, Inc. | 2023-08-10 |
| Carotid WALLSTENT Monorail Endoprosthesis (P050019/S039) | Boston Scientific Corp | 2023-08-10 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S025) | Berlin Heart, Inc. | 2023-08-10 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S018) | Medtronic, Inc. | 2023-08-10 |
| Freestyle Bioprosthesis (P980043/S076) | Medtronic, Inc. | 2023-08-10 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S086) | Syncardia Systems, LLC | 2023-08-09 |
| DETOUR System (P220021/S001) | Endologix, LLC | 2023-08-09 |
| 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/S755) | Medtronic, Inc. | 2023-08-09 |
| Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems (P160043/S066) | Medtronic Vascular | 2023-08-08 |
| QuickFlex µ, Quartet (P030054/S410) | ABBOTT MEDICAL | 2023-08-08 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032) | Boston Scientific Corporation | 2023-08-08 |
| AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set (P980037/S090) | Boston Scientific Corp | 2023-08-08 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S017) | Biotronik AG | 2023-08-07 |
| ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S030) | Biotronik AG | 2023-08-07 |
| Edwards Commander Delivery System (P200015/S043) | Edwards Lifesciences, LLC | 2023-08-05 |
| Edwards Commander Delivery System (P140031/S160) | Edwards Lifesciences, LLC | 2023-08-05 |
| WALLSTENT Endoprosthesis (P930031/S073) | Boston Scientific Corp | 2023-08-04 |
| VENOUS WALLSTENT Self-Expanding Stent (P980033/S063) | Boston Scientific Corporation | 2023-08-04 |
| RelayPro Thoracic Stent-Graft System (P200045/S006) | Bolton Medical, Inc. | 2023-08-04 |
| THERMOCOOL SMARTTOUCH® SF (P040036/S091) | Biosense Webster, Inc. | 2023-08-03 |
| ID/SN Label (P960004/S104) | Boston Scientific | 2023-08-03 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S140) | Boston Scientific Corp | 2023-08-03 |
| OPTIMIZER Smart Mini (OSM) system (P180036/S021) | Impulse Dynamics (Usa), Inc. | 2023-08-03 |
| 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/S756) | Medtronic, Inc. | 2023-08-03 |
| THERMOCOOL SMARTTOUCH® (P030031/S129) | Biosense Webster, Inc. | 2023-08-03 |
| 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/S757) | Medtronic, Inc. | 2023-08-01 |
| Epicardial Patch Lead, Epicardial Patch Lead, Upsizing Sleeve (P900061/S171) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S178) | Medtronic, Inc. | 2023-08-01 |
| Transvene CS/SVC Lead (P980050/S141) | Medtronic, Inc. | 2023-08-01 |
| Attain Bipolar OTW Lead, Attain OTW L V Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Seren (P010015/S524) | Medtronic, Inc. | 2023-08-01 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve System, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valv (P130021/S142) | Medtronic, Inc. | 2023-08-01 |
| CapSure Sense Lead, CapSure SP Lead, Vitatron Crystalline Lead (P830061/S218) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S114) | Medtronic, Inc. | 2023-08-01 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead, Subcut (P920015/S280) | Medtronic, Inc. | 2023-08-01 |
| Myocardial Pacing Lead (P120017/S033) | Medtronic, Inc. | 2023-08-01 |
| CapSureFix Novus Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S254) | Medtronic, Inc. | 2023-08-01 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S085) | Syncardia Systems, LLC | 2023-08-01 |
| CapSureFix MRI Lead (P090013/S329) | Medtronic, Inc. | 2023-08-01 |
| 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, Ev (P980016/S864) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead (P850089/S166) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| SelectSecure Lead (P030036/S144) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| CapSure Epicardial Pacing Lead (P950024/S108) | Medtronic, Inc. | 2023-08-01 |
| 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/S830) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| CardioMEMS Hospital System (P100045/S066) | ABBOTT MEDICAL | 2023-07-28 |
| DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION Coronary Orbital Atherectomy System (OAS) (P130005/S037) | Cardiovascular Systems, Inc. | 2023-07-28 |
| Medtronic Evolut R Transcatheter Aortic Valve Replacement System, Medtronic Evolut PRO Transcatheter Aortic Valve Replac (P130021/S140) | Medtronic, Inc. | 2023-07-28 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S076) | Boston Scientific Corp | 2023-07-27 |
| WOLVERINE Coronary Cutting Balloon (P950020/S139) | Boston Scientific Corp | 2023-07-27 |
| Cordis® PRECISE® Nitinol Stent System (P030047/S047) | Cordis US Corporation | 2023-07-27 |