| Perimount Aortic and Mitral Bioprostheses (P860057/S163) | Edwards Lifesciences, LLC | 2017-06-20 |
| 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/S595) | Medtronic Cardiac Rhythm Disease Management | 2017-06-20 |
| Sapien XT Transcatheter Heart Valve (P130009/S076) | Edwards Lifesciences, LLC | 2017-06-20 |
| EDWARDS INTUITY VALVE SYSTEM (P150036/S002) | Edwards Lifesciences, LLC | 2017-06-20 |
| HeartWare Ventricular Assist System (P100047/S093) | Medtronic | 2017-06-20 |
| CVX-300 and CVX-300P Excimer Laser Systems (P910001/S093) | Spectranetics Corp. | 2017-06-20 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESES/ THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX T (P860057/S156) | Edwards Lifesciences, LLC | 2017-06-20 |
| Sapien S3 Transcatheter Heart Valve (P140031/S042) | Edwards Lifesciences, LLC | 2017-06-20 |
| Evera MRI DF-1 ICD, Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR/ S VR/ XT DR/ XT VR ICD's ; Maximo II ICD; Pritectai I (P980016/S634) | Medtronic Cardiac Rhythm Disease Management | 2017-06-20 |
| Impella CP Ventricular Support System (P140003/S019) | Abiomed, Inc. | 2017-06-20 |
| Intuity Elite Valve System (P150036/S012) | Edwards Lifesciences, LLC | 2017-06-20 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S057) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| TAPSCOPE 550 - 200-0010, 200-0025, 250-0010, 250-0025 (P860008/S023) | Cardio Command | 2017-06-19 |
| GORE TIGRIS Vascular Stent (P160004/S004) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S002) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE TAG Thoracic Endoprosthesis (P040043/S093) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S038) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S144) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S099) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| Innova Vascular Self-Expanding Stent System (P140028/S027) | Boston Scientific Corporation | 2017-06-16 |
| Edwards Commander Delivery System (P140031/S044) | Edwards Lifesciences, LLC | 2017-06-16 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S143) | W. L. Gore & Associates, Inc. | 2017-06-16 |
| GORE CARDIOFORM Septal Occluder (P050006/S059) | W. L. Gore & Associates, Inc. | 2017-06-16 |
| GORE TAG Thoracic Endoprosthesis (P040043/S092) | W. L. Gore & Associates, Inc. | 2017-06-16 |
| Epic Vascular Self-Expanding Stent System (P110035/S041) | Boston Scientific Corp | 2017-06-16 |
| CardioMEMS HF System (P100045/S017) | ABBOTT MEDICAL | 2017-06-15 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S025) | Cook Ireland, Ltd. | 2017-06-15 |
| CardioMEMS PA Sensor and Delivery Catheter (P100045/S020) | ABBOTT MEDICAL | 2017-06-15 |
| SYNERGY Everolimus Eluting Coronary Stent System (P150003/S031) | Boston Scientific Corporation | 2017-06-14 |
| Innova Vascular Self-Expanding Stent System (P140028/S026) | Boston Scientific Corporation | 2017-06-14 |
| Chilli II Cooled Ablation Catheter (P980003/S075) | Boston Scientific Corp | 2017-06-13 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, Intella Tip MiFi Open-Irrigated Ab (P150005/S021) | Boston Scientific Corp | 2017-06-13 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S331) | Medtronic, Inc. | 2017-06-13 |
| HeartWare Ventricular Assist System (P100047/S092) | Medtronic | 2017-06-13 |
| ASTRA S DR MIR IPG, ASTRA S SR MRI IPG, ASTRA XT DR MRI, ASTRA XT SR MRI IPG (P980035/S505) | Medtronic, Inc. | 2017-06-13 |
| HeartWare Ventricular Assist System (P100047/S099) | Medtronic | 2017-06-13 |
| Durata / Optisure ( Passive); / Durata / Optisure (Active) (P950022/S106) | ABBOTT MEDICAL | 2017-06-13 |
| MYCARELINK PATIENT MONITOR MODEL (P890003/S368) | Medtronic, Inc. | 2017-06-09 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S314) | Medtronic, Inc. | 2017-06-09 |
| Amplia, Brava, Claria , Compia, Converto, Maximo, Protecta, Viva (P010031/S572) | Medtronic Cardiac Rhythm Disease Management | 2017-06-09 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S055) | Syncardia Systems, LLC | 2017-06-09 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/ Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S162) | Edwards Lifesciences, LLC | 2017-06-09 |
| REVO MRI SURESCAN IPG (P090013/S242) | Medtronic, Inc. | 2017-06-09 |
| Evera MRI, Evera XT DR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Virtuoso II (P980016/S612) | Medtronic Cardiac Rhythm Disease Management | 2017-06-09 |
| Adapta, Versa, Sensia IPGEnPulse E1 IPG Kappa DR (Kappa 700/600) (P980035/S483) | Medtronic, Inc. | 2017-06-09 |
| Edwards Intuity Valve System (P150036/S011) | Edwards Lifesciences, LLC | 2017-06-09 |
| MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S012) | Medtronic, Inc. | 2017-06-09 |
| Micra TPS (P150033/S023) | Medtronic, Inc. | 2017-06-08 |
| Evera, Maximo, Protecta, Secura, Solara Quadripolar,Syncra, Viva MRI DF XT ICD CRT-P (P980016/S632) | Medtronic Cardiac Rhythm Disease Management | 2017-06-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P, (P010015/S329) | Medtronic, Inc. | 2017-06-08 |
| Consulta, Percepta, Serena, Solara Bipolar CRT-P, Quadripolar CRT-P (P010015/S330) | Medtronic, Inc. | 2017-06-08 |
| Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta XT MRI/CRT-D, Viva Quad S AF VR ICD (P010031/S593) | Medtronic Cardiac Rhythm Disease Management | 2017-06-08 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S003) | Great Batch Medical | 2017-06-08 |
| Adapta, Versa, Sensia IPG ADDR01, ADSR01, ADDR03, ADVDD01, ADDRS1, ADSR03, SEDR01, ADDR06, ADDRL1, ADSR06, SESR01, VEDR0 (P980035/S507) | Medtronic, Inc. | 2017-06-08 |
| Evera MRI DF-1 ICD DVMB1D1, DDMB1D1, DDMC3D1, DVMC3D1; Evera MRI ICD DDMC3D4, DVMB1D4, DVMC3D4, DDMB1D4; Evera S DR ICD (P980016/S633) | Medtronic Cardiac Rhythm Disease Management | 2017-06-08 |
| HeartWare Left Ventricular Assist System (P100047/S096) | Medtronic | 2017-06-08 |
| Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02, W4TR02; Solara Bipolar CRT (P010015/S332) | Medtronic, Inc. | 2017-06-08 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG (P980035/S501) | Medtronic, Inc. | 2017-06-08 |
| Amplia MRI CRTD DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; DTBC1D1; Brava Quad CRTD (P010031/S594) | Medtronic Cardiac Rhythm Disease Management | 2017-06-08 |
| Revo MRI SureScan IPG RVDR01 (P090013/S257) | Medtronic, Inc. | 2017-06-08 |
| Adapta, Versa, Sensia IPG, Advisa DR/SR MRI IPG, ASTRA S DR MRI IPG, Relia IPG (P980035/S502) | Medtronic, Inc. | 2017-06-08 |
| NIRxcell CoCr Coronary Stent on RX (P110004/S022) | Medinol, Ltd. | 2017-06-07 |
| Edwards Crimper (P140031/S035) | Edwards Lifesciences, LLC | 2017-06-07 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOM (P010012/S449) | Boston Scientific Corp | 2017-06-06 |
| Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2. (P110042/S085) | Boston Scientific Corporation | 2017-06-06 |
| EXCOR Pediatric Ventricular Assist Device (P160035) | Berlin Heart, Inc. | 2017-06-06 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P, (P010015/S328) | Medtronic, Inc. | 2017-06-06 |
| GORE, VIATORR TIPS Endoprosthesis - with Controlled Expansion (P040027/S056) | W. L. Gore & Associates, Inc. | 2017-06-06 |
| Edwards SAPIEN 3 Transcatheter Heart Vlave (P140031/S034) | Edwards Lifesciences, LLC | 2017-06-06 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG (P980035/S500) | Medtronic, Inc. | 2017-06-06 |
| Implantable Cardioverter Defibrillator (ICD) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOMENTUM, VIGI (P960040/S392) | Boston Scientific | 2017-06-06 |
| Sprint Quattro Lead (P920015/S197) | Medtronic, Inc. | 2017-06-05 |
| Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S028) | Edwards Lifesciences, LLC | 2017-06-05 |
| Titan Device Tester (P980035/S504) | Medtronic, Inc. | 2017-06-05 |
| Adapta, Versa, Sensia IPG ADDRS1, ADSR01, ADDR03, SESR01, ADSR06, VEDR01, ADD01, SEDRL1, SED01, SES01, ADDR01, ADDRL1, A (P980035/S503) | Medtronic, Inc. | 2017-06-04 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG (P980035/S499) | Medtronic, Inc. | 2017-06-04 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P, (P010015/S327) | Medtronic, Inc. | 2017-06-04 |
| AngioJet Rheolytic Thrombectomy System (P980037/S065) | Boston Scientific Corp | 2017-06-02 |
| Endologix Powerlink System (P040002/S058) | Endologix, LLC | 2017-06-02 |
| Intella Tip MiFi XP cardiac ablation catheters (P020025/S098) | Boston Scientific | 2017-06-01 |
| Adapta, Versa, Sensia IPG ADSR01, ADDR01, ADDR06, ADDRL1, ADDRS1, VEDR01, ADD01, SEDRL1, SED01, SES01, ADDR03, SEDR01, A (P980035/S498) | Medtronic, Inc. | 2017-05-30 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S045) | ABBOTT MEDICAL | 2017-05-30 |
| Vaisala Environmental Monitoring System (P110016/S044) | ABBOTT MEDICAL | 2017-05-26 |
| Innova Self-Expanding Stent System (P140028/S025) | Boston Scientific Corporation | 2017-05-26 |
| Epic Vascular Self-Expanding Stent System (P110035/S040) | Boston Scientific Corp | 2017-05-26 |
| AED Plus and Fully Automatic AED Plus (P160015) | ZOLL Medical Corporation | 2017-05-26 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S161) | Boston Scientific Corp | 2017-05-26 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S030) | Boston Scientific Corporation | 2017-05-26 |
| MynxGrip Vascular Closure Device (P040044/S076) | Cordis US Corporation | 2017-05-26 |
| Edwards Intuity Elite Valve & Delivery System (P150036/S010) | Edwards Lifesciences, LLC | 2017-05-25 |
| Solia S (P950037/S174) | Biotronik, Inc. | 2017-05-24 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S048) | Syncardia Systems, LLC | 2017-05-24 |
| Plexa S 60/Plexa SD 60/16/Plexa ProMRI S/Plexa ProMRI SD/Plexa DF-1 S/Plexa DF-1 SD/Plexa ProMRI DF-1 SD/Plexa ProMRI DF (P980023/S081) | Biotronik, Inc. | 2017-05-24 |
| Fineline II Sterox and Sterox EZ Lead (P960004/S080) | Boston Scientific | 2017-05-23 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S074) | Edwards Lifesciences, LLC | 2017-05-23 |
| Ingevity Lead (P150012/S030) | Boston Scientific | 2017-05-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S039) | Edwards Lifesciences, LLC | 2017-05-23 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bio (P860057/S160) | Edwards Lifesciences, LLC | 2017-05-23 |
| EDWARDS INTUITY Valve System (P150036/S008) | Edwards Lifesciences, LLC | 2017-05-23 |
| EMBLEM S-ICD Pulse Generator (PG) & MRI S-ICD Pulse Generator (PG) (S-ICD's) (P110042/S084) | Boston Scientific Corporation | 2017-05-23 |