| Epic Vascular Self-Expanding Stent System (P110035/S056) | Boston Scientific Corp | 2020-05-05 |
| HeartWare Ventricular Assist System (P100047/S154) | Medtronic | 2020-05-05 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (P170003/S018) | Lutonix | 2020-05-04 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S739) | Medtronic Cardiac Rhythm Disease Management | 2020-05-04 |
| INGEVITY lead family (P150012/S094) | Boston Scientific | 2020-05-04 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad, Compia MRI, C (P010031/S700) | Medtronic Cardiac Rhythm Disease Management | 2020-05-04 |
| Adapta IPG, Versa IPG, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR M (P980035/S625) | Medtronic, Inc. | 2020-05-04 |
| TREO® Abdominal Stent-Graft System (P190015) | Bolton Medical, Inc. | 2020-05-04 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S435) | Medtronic, Inc. | 2020-05-04 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S036) | Lutonix | 2020-05-04 |
| EnVeo R, EnVeo PRO, Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R, PRO and PRO+ Systems (P130021/S074) | Medtronic, Inc. | 2020-05-01 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S077) | Syncardia Systems, LLC | 2020-05-01 |
| THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter, SF Bi-Directional Navigation (P030031/S105) | Biosense Webster, Inc. | 2020-04-30 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System - RX and OTW (P110013/S102) | Medtronic Vascular | 2020-04-30 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW (P160043/S035) | Medtronic Vascular | 2020-04-30 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S009) | Heartsine Technologies, Ltd. | 2020-04-30 |
| THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter (P040036/S073) | Biosense Webster, Inc. | 2020-04-30 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S008) | Bard Peripheral Vascular, Inc. | 2020-04-30 |
| SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S114) | Edwards Lifesciences, LLC | 2020-04-29 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S016) | Celonova Biosciences, Inc. | 2020-04-27 |
| Biocor, Biocor Supra, Epic, and Epic Supra Valves (P040021/S043) | ABBOTT MEDICAL | 2020-04-25 |
| Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Cool Path Duo, MediGuide Enabled, and Safi (P110016/S067) | ABBOTT MEDICAL | 2020-04-24 |
| Therapy Dual-8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter and Safire TX Ablation Catheter (P040042/S045) | Irvine Biomedical,Inc.(Ibi) | 2020-04-24 |
| Therapy Cool Path Ablation Catheter (including all braid catheter) (P060019/S047) | Irvine Biomedical, Inc. | 2020-04-24 |
| Alto Abdominal Stent Graft System (P120006/S034) | Endologix, LLC | 2020-04-24 |
| Therapy Ablation Catheter (including Bi-Directional Catheter) Therapy 4mm Thermistor Ablation Catheter (P040014/S039) | Irvine Biomedical, Inc. | 2020-04-24 |
| HeartWare HVAD System (P100047/S144) | Medtronic | 2020-04-24 |
| STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING (P830061/S173) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S MRI ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD (P010031/S699) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S111) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt H (P010031/S674) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S137) | Medtronic, Inc. | 2020-04-23 |
| Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD (P980016/S713) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| 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 (P980016/S738) | Medtronic Cardiac Rhythm Disease Management | 2020-04-23 |
| MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039/S202) | Medtronic, Inc. | 2020-04-23 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S234) | Medtronic, Inc. | 2020-04-23 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S301) | Medtronic, Inc. | 2020-04-23 |
| SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S416) | Medtronic, Inc. | 2020-04-23 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S434) | Medtronic, Inc. | 2020-04-22 |
| 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/S698) | Medtronic Cardiac Rhythm Disease Management | 2020-04-22 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, and Defibrillator, automatic (P050023/S146) | Biotronik, Inc. | 2020-04-22 |
| Defibrillator, implantable, dual-chamber (P000009/S085) | Biotronik, Inc. | 2020-04-22 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S004) | Defibtech, LLC | 2020-04-22 |
| Innova Self-Expanding Stent System (P140028/S058) | Boston Scientific Corporation | 2020-04-22 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S029) | Boston Scientific Corp | 2020-04-22 |
| Pulse Generator, Permanent, Implantable (P950037/S212) | Biotronik, Inc. | 2020-04-22 |
| Adapta, Versa, Sensia IPG, Advisa DR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, and Azure XT (P980035/S624) | Medtronic, Inc. | 2020-04-22 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC (P980016/S737) | Medtronic Cardiac Rhythm Disease Management | 2020-04-22 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S101) | Biotronik, Inc. | 2020-04-22 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB) (P170003/S016) | Lutonix | 2020-04-21 |
| LifeVest Wearable Defibrillator (P010030/S133) | Zoll Manufacturing Corporation | 2020-04-20 |
| Epic Vascular Self-Expanding Stent System (P110035/S059) | Boston Scientific Corp | 2020-04-20 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S030) | Boston Scientific Corp | 2020-04-20 |
| Innova Self-Expanding Stent System (P140028/S059) | Boston Scientific Corporation | 2020-04-20 |
| LifeVest Wearable Defibrillator (P010030/S134) | Zoll Manufacturing Corporation | 2020-04-18 |
| Edwards Commander Delivery System, Edwards Certitude Delivery System (P140031/S113) | Edwards Lifesciences, LLC | 2020-04-17 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S049) | Boston Scientific Corp | 2020-04-17 |
| Automated Impella Controller (P140003/S070) | Abiomed, Inc. | 2020-04-17 |
| Innova Vascular Self-Expanding Stent System (P140028/S053) | Boston Scientific Corporation | 2020-04-16 |
| Biosense Webster Cables (P990071/S043) | Biosense Webster, Inc. | 2020-04-16 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S025) | Boston Scientific Corp | 2020-04-16 |
| Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens (P010068/S059) | Biosense Webster, Inc. | 2020-04-16 |
| Amplatzer PFO Occluder (P120021/S015) | ABBOTT MEDICAL | 2020-04-16 |
| Micra AV Transcatheter Pacemaker System (P150033/S071) | Medtronic, Inc. | 2020-04-16 |
| Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St (P950005/S074) | Biosense Webster, Inc. | 2020-04-16 |
| Amplatzer Muscular VSD Occluder (P040040/S040) | ABBOTT MEDICAL | 2020-04-16 |
| FlexAbility and FlexAbility SE Ablation Catheter (P110016/S068) | ABBOTT MEDICAL | 2020-04-16 |
| LifeVest Wearable Defibrillator (P010030/S135) | Zoll Manufacturing Corporation | 2020-04-16 |
| Livewire TC Ablation Catheter and Safire Ablation Catheter (P960016/S081) | St Jude Medical | 2020-04-16 |
| Amplatzer Septal Occluder (P000039/S070) | ABBOTT MEDICAL | 2020-04-16 |
| EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca (P040036/S072) | Biosense Webster, Inc. | 2020-04-16 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, and Amplatzer Piccolo Occluder (P020024/S060) | ABBOTT MEDICAL | 2020-04-16 |
| HeartMate 3 (HM3) Left Ventricular Assist System (P160054/S028) | ABBOTT MEDICAL | 2020-04-16 |
| TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S059) | St Jude Medical | 2020-04-16 |
| Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (P030031/S104) | Biosense Webster, Inc. | 2020-04-16 |
| CentriMag Circulatory Support System (P170038/S003) | Abbott | 2020-04-16 |
| EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables (P990025/S059) | Biosense Webster, Inc. | 2020-04-16 |
| INGEVITY MRI Lead and INGEVITY non-MRI Lead (P150012/S093) | Boston Scientific | 2020-04-16 |
| Amplatzer PFO Occluder (P120021/S014) | ABBOTT MEDICAL | 2020-04-15 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolara CRT-P, Sol (P010015/S432) | Medtronic, Inc. | 2020-04-15 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D (P980035/S622) | Medtronic, Inc. | 2020-04-15 |
| Amplatzer Septal Occluder/Amplatzer Cribriform Occluder (P000039/S069) | ABBOTT MEDICAL | 2020-04-15 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot (P980016/S735) | Medtronic Cardiac Rhythm Disease Management | 2020-04-15 |
| Amplatzer Muscular VSD Occluder (P040040/S039) | ABBOTT MEDICAL | 2020-04-15 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Compia MRI CRT-D, Compia MRI Q (P010031/S696) | Medtronic Cardiac Rhythm Disease Management | 2020-04-15 |
| Tack Endovascular System (6F) (P180034/S002) | Philips Image Guided Therapy Corporation | 2020-04-15 |
| Amplatzer Duct Occluder/Amplatzer Duct Occluder II/Amplatzer Piccolo Occluder (P020024/S059) | ABBOTT MEDICAL | 2020-04-15 |
| CardioMEMS HF System (P100045/S042) | ABBOTT MEDICAL | 2020-04-14 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot (P980016/S736) | Medtronic Cardiac Rhythm Disease Management | 2020-04-14 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S433) | Medtronic, Inc. | 2020-04-14 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D (P980035/S623) | Medtronic, Inc. | 2020-04-14 |
| Edwards INTUITY Elite Tube Extrusion (P150036/S051) | Edwards Lifesciences, LLC | 2020-04-14 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Compia MRI CRT-D, Compia MRI Q (P010031/S697) | Medtronic Cardiac Rhythm Disease Management | 2020-04-14 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S057) | Boston Scientific Corporation | 2020-04-13 |
| Epic Vascular Self-Expanding Stent System (P110035/S058) | Boston Scientific Corp | 2020-04-13 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S080) | Boston Scientific Corp | 2020-04-13 |
| Livewire TC Ablation Catheter (P960016/S082) | St Jude Medical | 2020-04-13 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S037) | Boston Scientific Corp | 2020-04-11 |
| GORE EXCLUDER AAA Endoprosthesis product family (P020004/S174) | W. L. Gore & Associates, Inc. | 2020-04-10 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve (P150048/S043) | Edwards Lifesciences, LLC | 2020-04-10 |