| GORE CARDIOFORM ASD Occluder (P050006/S078) | W. L. Gore & Associates, Inc. | 2019-07-11 |
| Bard E-Luminexx Vascular Stent (P080007/S022) | Bard Peripheral Vascular, Inc. | 2019-07-11 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S598) | Medtronic, Inc. | 2019-07-11 |
| Consulta CRT-P, Syncra CRT-P, and Viva CRT-P (P010015/S410) | Medtronic, Inc. | 2019-07-11 |
| 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/S671) | Medtronic Cardiac Rhythm Disease Management | 2019-07-11 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S126) | Boston Scientific Corporation | 2019-07-11 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S009) | Physio-Control, Inc. | 2019-07-10 |
| Cordis Incraft AAA Stent Graft System (P150002/S005) | Cordis US Corporation | 2019-07-10 |
| MitraClip G4 System (P100009/S029) | ABBOTT MEDICAL | 2019-07-09 |
| HeartWare HVAD System (P100047/S138) | Medtronic | 2019-07-09 |
| Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S032) | Boston Scientific Corp | 2019-07-09 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE and PROPONENT Pacemaker Devices (N970003/S239) | Boston Scientific Corp | 2019-07-08 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT and PERCIVA CRT-D Res (P010012/S502) | Boston Scientific Corp | 2019-07-08 |
| CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST and VALITUDE (P030005/S182) | Guidant Corp. | 2019-07-08 |
| LATITUDE Programming System (P910077/S172) | Boston Scientific | 2019-07-08 |
| LATITUDE Programming System (P910077/S169) | Boston Scientific | 2019-07-08 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S498) | Boston Scientific Corp | 2019-07-08 |
| Pacemaker Devices: ADVANTIO, INEGNIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT (N970003/S236) | Boston Scientific Corp | 2019-07-08 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI PROPONENT MRI and ACCOLADE MRI (P150012/S076) | Boston Scientific | 2019-07-08 |
| Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S073) | Boston Scientific | 2019-07-08 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERCIVA ICD Devic (P960040/S437) | Boston Scientific | 2019-07-08 |
| ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S434) | Boston Scientific | 2019-07-08 |
| INVIVE, INTUA, VISIONIST and VALITUDE CRT-P Resynchronization Devices (P030005/S184) | Guidant Corp. | 2019-07-08 |
| HeartWare Ventricular Assist System (P100047/S141) | Medtronic | 2019-07-05 |
| Impella CP with SmartAssist (P140003/S055) | Abiomed, Inc. | 2019-07-03 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S010) | ZOLL Medical Corporation | 2019-07-03 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S008) | Great Batch Medical | 2019-07-03 |
| CapSure VDD-2 and Vitatron Brilliant S+VDD Lead (P890003/S415) | Medtronic, Inc. | 2019-07-02 |
| Tryton Side Branch Stent (P150039/S004) | Poseidon Medical, Inc. | 2019-07-02 |
| CoreValve Evolut R and CoreValve Evolut PRO transcatheter aortic valves (TAV) (P130021/S060) | Medtronic, Inc. | 2019-07-02 |
| HeartWare HVAD System (P100047/S134) | Medtronic | 2019-07-02 |
| CapSure Epicardial Pacing Lead (P950024/S086) | Medtronic, Inc. | 2019-07-02 |
| Impella RP System (P170011/S013) | Abiomed, Inc. | 2019-06-28 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD Systems (P140003/S053) | Abiomed, Inc. | 2019-06-28 |
| Avalus Bioprosthesis (P170006/S014) | Medtronic, Inc. | 2019-06-28 |
| Spectranetics Laser Sheath (SLS) II and GlideLight Laser Sheath (P960042/S066) | Spectranetics (Philips) | 2019-06-28 |
| Impella 5.0/LD (P140003/S054) | Abiomed, Inc. | 2019-06-28 |
| Impella RP System (P170011/S012) | Abiomed, Inc. | 2019-06-28 |
| HeartWare Left Ventricular Assist Device System (P100047/S140) | Medtronic | 2019-06-28 |
| Artic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S093) | Medtronic Cryocath, LP | 2019-06-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S046) | Medtronic, Inc. | 2019-06-27 |
| Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S134) | Medtronic, Inc. | 2019-06-27 |
| HV Splitter/Adaptor Kit and Sprint Quattro Lead (P920015/S231) | Medtronic, Inc. | 2019-06-27 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta D (P980035/S597) | Medtronic, Inc. | 2019-06-26 |
| Attain StarFix Lead (P060039/S094) | Medtronic, Inc. | 2019-06-26 |
| CapSure VDD-2 Leadand Vitatron Brilliant S+ VDD Lead (P890003/S413) | Medtronic, Inc. | 2019-06-26 |
| CapSureFix MRI Lead (P090013/S299) | Medtronic, Inc. | 2019-06-26 |
| CapSure Epicardial Pacing Lead (P950024/S085) | Medtronic, Inc. | 2019-06-26 |
| AtriCure Synergy Ablation System (P100046/S010) | AtriCure, Inc. | 2019-06-26 |
| Transvene CS/SVC Lead (P980050/S122) | Medtronic, Inc. | 2019-06-26 |
| Epicardial Patch Lead (P900061/S154) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| Amplia MRI CRT-D, Amplia MRI Quard CRt-P, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S670) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| CapSure Sense Lead, CapSure SP Novus Lead and VItatron Crystalline Lead (P830061/S170) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| SelectSecure Lead (P030036/S110) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| Myocardial Packing Lead (P120017/S018) | Medtronic, Inc. | 2019-06-26 |
| HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Transvene CS/SVC Lead and Sprint Quattro Lead (P920015/S232) | Medtronic, Inc. | 2019-06-26 |
| 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 VR/DR ICD, Prot (P980016/S710) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S199) | Medtronic, Inc. | 2019-06-26 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S069) | Syncardia Systems, LLC | 2019-06-26 |
| CapSure SP Novus Lead, CapSure Sp Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S141) | Medtronic Cardiac Rhythm Disease Management | 2019-06-26 |
| Micra TPS (P150033/S055) | Medtronic, Inc. | 2019-06-26 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, COnsulat CRT-P, Percepa Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena B (P010015/S409) | Medtronic, Inc. | 2019-06-26 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S135) | Medtronic, Inc. | 2019-06-26 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S172) | Medtronic Cardiac Rhythm Disease Management | 2019-06-24 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S412) | Medtronic, Inc. | 2019-06-24 |
| HV Splitter/Adaptor kit and Sprint Quattro Lead (P920015/S233) | Medtronic, Inc. | 2019-06-24 |
| HeartLight Endoscopic Ablation System (P150026/S006) | Cardiofocus, Inc. | 2019-06-24 |
| CapSure VDD-2 Lead and Vitatron Brilliant S+VDD Lead (P890003/S414) | Medtronic, Inc. | 2019-06-24 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S008) | Lutonix | 2019-06-24 |
| CapSureFix MRI Lead (P090013/S300) | Medtronic, Inc. | 2019-06-24 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S201) | Medtronic, Inc. | 2019-06-24 |
| Attain StarFix Lead (P060039/S095) | Medtronic, Inc. | 2019-06-24 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S142) | Medtronic Cardiac Rhythm Disease Management | 2019-06-24 |
| Attain Ability Lead and Attain Performa Lead (P080006/S136) | Medtronic, Inc. | 2019-06-24 |
| LifeVst Wearable Defibrillator (P010030/S118) | Zoll Manufacturing Corporation | 2019-06-24 |
| LOTUS Edge Valve System (P180029/S004) | Boston Scientific Corporation | 2019-06-22 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S669) | Medtronic Cardiac Rhythm Disease Management | 2019-06-21 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S408) | Medtronic, Inc. | 2019-06-21 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S596) | Medtronic, Inc. | 2019-06-21 |
| PRECISE PRO RX Nitinol Stent System (P030047/S039) | Cordis US Corporation | 2019-06-21 |
| NG3 and NG4 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S505) | Boston Scientific Corp | 2019-06-21 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S709) | Medtronic Cardiac Rhythm Disease Management | 2019-06-21 |
| NG3 and NG4 Implantable Cardioverter Defibrillators (ICDs) (P960040/S439) | Boston Scientific | 2019-06-21 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S041) | Cordis US Corporation | 2019-06-21 |
| INCRAFT(R) AAA Stent Graft System (P150002/S004) | Cordis US Corporation | 2019-06-21 |
| Accolade Pacemakers (N970003/S240) | Boston Scientific Corp | 2019-06-21 |
| Mynx CONTROL Vascular Closure Device (P040044/S084) | Cordis US Corporation | 2019-06-21 |
| EXOSEAL vascular Closure Device (P100013/S020) | Cordis US Corporation | 2019-06-21 |
| S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System (P120002/S016) | Cordis US Corporation | 2019-06-21 |
| Accolade MRI Pacemakers (P150012/S079) | Boston Scientific | 2019-06-21 |
| Accolade CRT Pacemakers (CRT-Ps) (P030005/S185) | Guidant Corp. | 2019-06-21 |
| Incraft (R) AAA Stent Graft System (P150002/S003) | Cordis US Corporation | 2019-06-21 |
| CapSureFix Novus Lead (P930039/S200) | Medtronic, Inc. | 2019-06-19 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S047) | St Jude Medical | 2019-06-19 |
| Sprint Quattro Lead (P920015/S230) | Medtronic, Inc. | 2019-06-19 |
| CapSure Sense Lead (P830061/S171) | Medtronic Cardiac Rhythm Disease Management | 2019-06-19 |
| RELIANCE 4-FRONT Steroid Eluting Leads (P910073/S156) | Boston Scientific | 2019-06-19 |
| LOTUS Edge Valve System (P180029/S006) | Boston Scientific Corporation | 2019-06-19 |
| VenaSeal Closure System (P140018/S015) | Medtronic Vascular, Inc. | 2019-06-19 |
| samaritan Public Access Automated External Defibrillators (P160008/S006) | Heartsine Technologies, Ltd. | 2019-06-19 |