| Resolute Integrity Coronary Stent Systems (P110013/S099) | Medtronic Vascular | 2019-08-12 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S019) | ABBOTT MEDICAL | 2019-08-12 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S072) | ABBOTT MEDICAL | 2019-08-12 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P150003/S051) | Boston Scientific Corporation | 2019-08-09 |
| Zoll R Series (P160022/S011) | ZOLL Medical Corporation | 2019-08-09 |
| LifeVest Wearable Defibrillator (P010030/S123) | Zoll Manufacturing Corporation | 2019-08-09 |
| Evera MRI DF-1, Evera S DR/VR, Evera XT DR/VR, Mirro MRI DR/VR, Primo MRI DR/VR, Protecta VR/XT, Secura DR, Visia AF MRI (P980016/S716) | Medtronic Cardiac Rhythm Disease Management | 2019-08-06 |
| Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara quadripolar (P010015/S416) | Medtronic, Inc. | 2019-08-06 |
| MANTA Vascular Closure Device (P180025/S005) | Teleflex Medical, LLC | 2019-08-06 |
| Amplia MRI/Quad, Brava/Quad, Claria MRI/Quad, Compia MRI/Quad, Consulta, Protecta/XT, Viava Quad S/XT, Viva S/XT CRT-D (P010031/S677) | Medtronic Cardiac Rhythm Disease Management | 2019-08-06 |
| Adapta, Versa, Sensia, Advisa DR/SR MRI, Astra S DR/SR MRI, Astra XT DR/SR, Attesta DR/SR MRI, Azure S DR/SR MRI, Relia, (P980035/S602) | Medtronic, Inc. | 2019-08-06 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S005) | Berlin Heart, Inc. | 2019-08-05 |
| EZ Steer Thermocool NAV Catheter and Navistar Thermocool (P040036/S068) | Biosense Webster, Inc. | 2019-08-02 |
| Celsius Catheter (P950005/S072) | Biosense Webster, Inc. | 2019-08-02 |
| Celsius, EZ Steer, and Navistar Thermocool Catheter (P030031/S099) | Biosense Webster, Inc. | 2019-08-02 |
| 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/S582) | Medtronic, Inc. | 2019-08-01 |
| Micra TPS (P150033/S050) | Medtronic, Inc. | 2019-08-01 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S398) | Medtronic, Inc. | 2019-08-01 |
| Evera RI 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, Mi (P980016/S701) | Medtronic Cardiac Rhythm Disease Management | 2019-08-01 |
| 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, Compia (P010031/S661) | Medtronic Cardiac Rhythm Disease Management | 2019-08-01 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S020) | Abbott Vascular, Inc. | 2019-07-31 |
| Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, and Origen Cardiac Resynchronization Therapy Defibrillators (CRT (P010012/S504) | Boston Scientific Corp | 2019-07-31 |
| Ingevity MRI Leads and Slit Suture Sleeve Accessory for Ingevity Leads (P150012/S078) | Boston Scientific | 2019-07-31 |
| Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, and Origen Implantable Cardioverter Defibrillators (ICD (P960040/S438) | Boston Scientific | 2019-07-31 |
| Reliance 4-Front Leads, Suture Sleeve Accessory for Reliance 4-Front Leads, Endotak Reliance 4-Site Leads and Endotak Re (P910073/S155) | Boston Scientific | 2019-07-31 |
| FineLine II Sterox Leads, Fineline II Sterox EZ Leads, and Suture Sleeve Accessories for FineLine II Leads (P960004/S090) | Boston Scientific | 2019-07-31 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S105) | Abbott Vascular, Inc. | 2019-07-30 |
| Avalus Bioprosthesis (P170006/S013) | Medtronic, Inc. | 2019-07-29 |
| Medtronic RF Ablation Catheters (P930029/S065) | Medtronic, Inc. | 2019-07-29 |
| Reply/Esprit (5th generation) Electric Hybrid Module (P950029/S123) | MicroPort CRM USA, Inc. | 2019-07-29 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S087) | Edwards Lifesciences, LLC | 2019-07-29 |
| LifeVest Wearable Defibrillator (P010030/S120) | Zoll Manufacturing Corporation | 2019-07-29 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S414) | Medtronic, Inc. | 2019-07-26 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S600) | Medtronic, Inc. | 2019-07-26 |
| MISAGO RX Self-expanding Peripheral Stent (P140002/S019) | Terumo Medical Corporation | 2019-07-26 |
| MitraClip NTR/XTR Clip Delivery System and Steerable Guide Catheter (P100009/S031) | ABBOTT MEDICAL | 2019-07-26 |
| MitraClip XTR Clip Delivery System (P100009/S033) | ABBOTT MEDICAL | 2019-07-26 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S675) | Medtronic Cardiac Rhythm Disease Management | 2019-07-26 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S714) | Medtronic Cardiac Rhythm Disease Management | 2019-07-26 |
| Carbomedics Prosthetic Heart Valve (CPHV) (P900060/S060) | Corcym S.r.l. | 2019-07-26 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S061) | Boston Scientific Corp | 2019-07-25 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S041) | Boston Scientific Corporation | 2019-07-25 |
| WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S065) | Boston Scientific Corp | 2019-07-25 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S167) | Boston Scientific Corp | 2019-07-25 |
| EPIC SELF-EXPANDING NITINOL STENT SYSTEM (P110035/S051) | Boston Scientific Corp | 2019-07-25 |
| BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S097) | Boston Scientific Corp | 2019-07-25 |
| FLEXATOME CUTTING BALLOON (P950020/S098) | Boston Scientific Corp | 2019-07-25 |
| Powerheart G5 Automated External Defibrillator (P160033/S002) | ZOLL Medical Corporation | 2019-07-25 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S048) | Boston Scientific Corporation | 2019-07-25 |
| ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER (P980037/S075) | Boston Scientific Corp | 2019-07-25 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S031) | Boston Scientific Corp | 2019-07-25 |
| WALLSTENT(R) ILIAC ENDOPROSTHESIS (P940019/S056) | Boston Scientific Scimed, Inc. | 2019-07-25 |
| LOTUS Edge Valve System (P180029/S007) | Boston Scientific Corporation | 2019-07-25 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S009) | Boston Scientific Corp | 2019-07-25 |
| WALLSTENT ENDOPROSTHESIS (P980033/S055) | Boston Scientific Corporation | 2019-07-25 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S050) | Boston Scientific Corporation | 2019-07-25 |
| TACTICATH QUARTZ SET (P130026/S049) | St Jude Medical | 2019-07-24 |
| Baseline Operating System Software (BOSS) for CareLink and Encore Programmers (P890003/S411) | Medtronic, Inc. | 2019-07-23 |
| Attain, Ability, Performa, Stability Quard MRI Lead (P080006/S138) | Medtronic, Inc. | 2019-07-22 |
| Amplia, Amplia Quad; Brava, Brava Quad; Claria, Claria Quad; Compia, Compia Quad; Consulta; Protecta, Protecta XT; Viva (P010031/S676) | Medtronic Cardiac Rhythm Disease Management | 2019-07-22 |
| CapSure VDD-2; Vitatron Brilliant S+VDD Lead (P890003/S417) | Medtronic, Inc. | 2019-07-22 |
| Lotus Edge Valve System (P180029/S002) | Boston Scientific Corporation | 2019-07-22 |
| Capsure Epicardial Pacing Lead (P950024/S087) | Medtronic, Inc. | 2019-07-22 |
| HV Splitter/Adoptor Kit; Sprint Quattro; Subcutaneous Lead; Transvene CS/SVC Lead (P920015/S235) | Medtronic, Inc. | 2019-07-22 |
| CapSureFix, Novus Lead (P930039/S203) | Medtronic, Inc. | 2019-07-22 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S112) | Medtronic Cardiac Rhythm Disease Management | 2019-07-22 |
| Evera, S, XT, DR, VR, Mirro, Primo MRI, DR, VR; Protecta VR, XT; Secura; Visia AF, MRI, VR ICD (P980016/S715) | Medtronic Cardiac Rhythm Disease Management | 2019-07-22 |
| Attain Bipolar OTW Lead, OTW LV Lead; Serena, Solara Quadripolar CRT-P (P010015/S415) | Medtronic, Inc. | 2019-07-22 |
| CapSure Sense, SP Novus; Vitaron Crystalline Lead (P830061/S174) | Medtronic Cardiac Rhythm Disease Management | 2019-07-22 |
| Capsure SP, Z, Novus Lead; Vitatron Impulse II Lead. (P850089/S143) | Medtronic Cardiac Rhythm Disease Management | 2019-07-22 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S105) | Biotronik, Inc. | 2019-07-19 |
| Pulse Generator, Permanent, Inplantable (P950037/S203) | Biotronik, Inc. | 2019-07-19 |
| PSW 1901 U (P950037/S200) | Biotronik, Inc. | 2019-07-18 |
| Advisa DR, DR MRI, and SR MRI IPG, Astra S DR MRI, S SR MRI, XT DR MRI, and XT SR MRI IPG, Azure S DR MRI, S SR MRI, XT (P980035/S599) | Medtronic, Inc. | 2019-07-18 |
| Percepta Bipolar and Quadripolar CRT-P, Serena Bipolar and Quadripolar CRT-P, Solar Bipolar and Quadripolar CRT-P (P010015/S413) | Medtronic, Inc. | 2019-07-18 |
| PSW 1901.U (P000009/S079) | Biotronik, Inc. | 2019-07-18 |
| Evera MRI DF-1, MRI, S DR, S VR, XT DR, and XT VR ICD, Mirro MRI DR and MRI VR ICD, Primo MRI DR and MRI VR ICD, Protect (P980016/S712) | Medtronic Cardiac Rhythm Disease Management | 2019-07-18 |
| PSW 1901.U (P050023/S130) | Biotronik, Inc. | 2019-07-18 |
| PSW 1901.U (P070008/S101) | Biotronik, Inc. | 2019-07-18 |
| Momentum, Resonate, Autogen, and Dynagen (CRT-D) (P010012/S507) | Boston Scientific Corp | 2019-07-18 |
| SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System (P030011/S071) | Syncardia Systems, LLC | 2019-07-18 |
| Visionist and Valitude (CRT-P) (P030005/S187) | Guidant Corp. | 2019-07-18 |
| Amplia MRI and MRI Quad CRT-D, Brava CRT-D and Quad CRT-D, Claria MRI and MRI Quad CRT-D, Compia MRI and MRI Quad CRT-D, (P010031/S673) | Medtronic Cardiac Rhythm Disease Management | 2019-07-18 |
| MitraClip NT, NTR, and XTR Clip Delivery System (P100009/S032) | ABBOTT MEDICAL | 2019-07-18 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S119) | Zoll Manufacturing Corporation | 2019-07-18 |
| Freestyle Bioprosthesis (P970031/S066) | Medtronic, Inc. | 2019-07-17 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S033) | Medinol, Ltd. | 2019-07-17 |
| Mosaic Bioprosthesis (P990064/S079) | Medtronic, Inc. | 2019-07-17 |
| Avalus Bioprosthesis (P170006/S015) | Medtronic, Inc. | 2019-07-17 |
| Melody Transcatheter Pulmonary Valve (TPV) System (P140017/S015) | Medtronic, Inc. | 2019-07-17 |
| Hancock Valved Conduit (P870078/S046) | Medtronic, Inc. | 2019-07-17 |
| Hancock II Bioprosthesis (P980043/S071) | Medtronic, Inc. | 2019-07-17 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S018) | Medinol, Ltd. | 2019-07-17 |
| Hancock Valved Conduit (P790007/S061) | Medtronic Heart Valves | 2019-07-17 |
| LIFEPAK 1000 defibrillator (P160026/S007) | Physio-Control, Inc. | 2019-07-16 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S007) | Great Batch Medical | 2019-07-15 |
| XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIEN (P110019/S105) | Abbott Vascular | 2019-07-12 |
| XIENCE V Everolimus Eluting Coronary Stent Systemand XIENCE nano Everolimus Eluting Coronary Stent System (P070015/S145) | Abbott Vascular, Inc. | 2019-07-12 |
| Lotus Edge Valve System (P180029/S005) | Boston Scientific Corporation | 2019-07-11 |
| 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, (P980016/S711) | Medtronic Cardiac Rhythm Disease Management | 2019-07-11 |