| MEDTRONIC COREVALVE(R) SYSTEM (P130021/S026) | Medtronic, Inc. | 2016-12-12 |
| LATITUDE NXT System (P910077/S154) | Boston Scientific | 2016-12-12 |
| ESSENTIO Models L100, L101, L121; PROPONENT Models L200, L201, L221; ACCOLADE Models L300, L301, L321; PROPONENT MRI Mod (N970003/S199) | Boston Scientific Corp | 2016-12-12 |
| AUTOGEN EL ICD MODELS D160, D161, D162, D163. (P960040/S374) | Boston Scientific | 2016-12-12 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S026) | Boston Scientific Corporation | 2016-12-12 |
| PROMUS(ELEMENT PLUS /PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S136) | Boston Scientific Corp | 2016-12-12 |
| INVIVE CRT-P Models V172, V173; INTUA CRT-P Models V272, V273; VALITUDE Model U125; VALITUDE X4 Model U128; (P030005/S147) | Guidant Corp. | 2016-12-12 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S086) | Medtronic, Ireland | 2016-12-09 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S067) | Medtronic Vascular | 2016-12-09 |
| PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S094) | Abbott Vascular, Inc. | 2016-12-08 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S057) | Cook, Inc. | 2016-12-08 |
| PRECISE NITINOL STENT SYSTEM (P030047/S033) | Cordis US Corporation | 2016-12-08 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S135) | Boston Scientific Corp | 2016-12-07 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MO & OTW (P150003/S015) | Boston Scientific Corporation | 2016-12-07 |
| IMPELLA CP Systems (P140003/S012) | Abiomed, Inc. | 2016-12-07 |
| MEDTRONIC ATTAIN ABILITY, MRI SURESCAN AND ATTAIN PERFORMA MRI SURESCAN (P080006/S102) | Medtronic, Inc. | 2016-12-07 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S025) | Boston Scientific Corporation | 2016-12-07 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S127) | Boston Scientific Corp | 2016-12-07 |
| INGEVITY (P150012/S019) | Boston Scientific | 2016-12-07 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S032) | Boston Scientific Corp | 2016-12-07 |
| Application Software for Micra Transcatheter Pacing System MC1VR01 (P150033/S009) | Medtronic, Inc. | 2016-12-06 |
| IntellaNav XP, IntellaNav MiFi XP Ablation Catheters (P020025/S092) | Boston Scientific | 2016-12-06 |
| CHILLI II ABLATION CATHETER. (P980003/S071) | Boston Scientific Corp | 2016-12-06 |
| Blazer OI & IntellaNav OI Ablation Catheters (P150005/S012) | Boston Scientific Corp | 2016-12-06 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S026) | Medtronic, Inc. | 2016-12-06 |
| Edwards Certitude Delivery System (P140031/S024) | Edwards Lifesciences, LLC | 2016-12-02 |
| PALMAZ BALLOON EXPANDABLE STENT (P890017/S019) | Cordis US Corporation | 2016-12-01 |
| VENASEAL CLOSURE SYSTEM (P140018/S005) | Medtronic Vascular, Inc. | 2016-12-01 |
| IMPELLA VENTRICULAR SUPPORT SYSTEM (P140003/S008) | Abiomed, Inc. | 2016-12-01 |
| WOLVERINE CORONARY CUTTING BALLOON MONORAIL (MR) AND OVER-THE WIRE (OTW) (P950020/S077) | Boston Scientific Corp | 2016-12-01 |
| Wolverine Coronary Cutting Balloon (Monorail) (P950020/S076) | Boston Scientific Corp | 2016-12-01 |
| OPEN PIVOT MECHANICAL HEART VALVES AND OPEN PIVOT AORTIC VALVED GRAFT (P990046/S048) | Medtronic Ats Medical, Inc. | 2016-12-01 |
| AngioJet Ultra Thrombectomy System Console (P980037/S061) | Boston Scientific Corp | 2016-12-01 |
| SJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit (P810002/S098) | ABBOTT MEDICAL | 2016-12-01 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S063) | ABBOTT MEDICAL | 2016-12-01 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM, ANGIOJET ULTRA DISTAFLEX THROMBECTOMY SET (P980037/S060) | Boston Scientific Corp | 2016-12-01 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S034) | W. L. Gore & Associates, Inc. | 2016-12-01 |
| Innova Vascular Self-Expanding Stent With Delivery System (P140028/S020) | Boston Scientific Corporation | 2016-12-01 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S095) | W. L. Gore & Associates, Inc. | 2016-12-01 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S018) | Boston Scientific | 2016-11-30 |
| LifeVest Wearable Defibrillator (P010030/S081) | Zoll Manufacturing Corporation | 2016-11-30 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S013) | ABBOTT MEDICAL | 2016-11-30 |
| VALITUDE, VALITUDE X4 (P030005/S146) | Guidant Corp. | 2016-11-30 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S198) | Boston Scientific Corp | 2016-11-30 |
| EMBLEM MRI S-CD Pulse Generator (PG) Model A219, EMBLEM S-CD Pulse Generator (PG) Model A209 (P110042/S069) | Boston Scientific Corporation | 2016-11-29 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S023) | Boston Scientific Corporation | 2016-11-29 |
| GORE VIATORR TIPS (P040027/S052) | W. L. Gore & Associates, Inc. | 2016-11-29 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S086) | Medtronic | 2016-11-28 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S022) | Medtronic Vascular, Inc. | 2016-11-25 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S021) | Medtronic Vascular, Inc. | 2016-11-23 |
| Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CRT-D SureScan; Compia MRI CRT-D SureScan (P010031/S568) | Medtronic Cardiac Rhythm Disease Management | 2016-11-23 |
| Evera MRI XT DR, VR, S DR, S VR SureScan ICD; Visia AF MRI XT, S VR SureScan ICD (P980016/S608) | Medtronic Cardiac Rhythm Disease Management | 2016-11-23 |
| Sprint Quattro Lead (P920015/S187) | Medtronic, Inc. | 2016-11-22 |
| ThermoCool SmartTouch SF Bi-Directional & Uni-Directional Navigation Catheter's (P030031/S079) | Biosense Webster, Inc. | 2016-11-22 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S006) | Abbott Vascular, Inc. | 2016-11-22 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S078) | Medtronic Vascular | 2016-11-22 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S053) | Medtronic, Inc. | 2016-11-21 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S001) | Boston Scientific Corp | 2016-11-21 |
| MOSAIC PORCINE BIOPROSTHETIC (P990064/S064) | Medtronic, Inc. | 2016-11-21 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S049) | Medtronic Heart Valves | 2016-11-21 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S055) | Medtronic, Inc. | 2016-11-21 |
| HANCOCK LOWPOROSITY VALVED CONDUIT (P870078/S034) | Medtronic, Inc. | 2016-11-21 |
| Durata Family Of High Voltage Leads (P950022/S097) | ABBOTT MEDICAL | 2016-11-20 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S480) | Medtronic, Inc. | 2016-11-20 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S023) | Boston Scientific Corporation | 2016-11-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S024) | Boston Scientific Corporation | 2016-11-18 |
| MyCareLink Patient Monitor Model 24950 (P890003/S365) | Medtronic, Inc. | 2016-11-17 |
| ALLURE QUADRA, RF, MP (P030035/S150) | ABBOTT MEDICAL | 2016-11-17 |
| REVO MRI SURESCAN IPG (P090013/S235) | Medtronic, Inc. | 2016-11-17 |
| Evera MRI; S DR,VR;XT DR,VR, ICD; Intrinsic 30 ICD; Marquis VR ICD; Maximo II ICD; Protecta XT ICD; Secura ICD; Virtuoso (P980016/S600) | Medtronic Cardiac Rhythm Disease Management | 2016-11-17 |
| Commander Delivery System (Including Loader) (P140031/S018) | Edwards Lifesciences, LLC | 2016-11-17 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER, AROTIC FRONT/AROTIC FRONT ADVANCE /AROTIC FRONT ADVANCE ST CARDIAC CRYOABLATI (P100010/S059) | Medtronic Cryocath, LP | 2016-11-17 |
| FREEZOR CARDIAC CRYOABLATION CATHETER /XTRA SUGICAL/ MAX SURGICAL CARDIA CRYOABLATION DEVICES, STERILE ACCESSORIES COAX (P020045/S077) | Medtronic Cryocath, LP | 2016-11-17 |
| Adapta, Versa, Sensia IPG; Advisa DR MRI IPG; EnPulse E1,E2 IPG; Kappa D (Kappa 700,900) IPG; Kappa DR (Kappa 650/700/60 (P980035/S474) | Medtronic, Inc. | 2016-11-17 |
| CURRENT AND FORTIFY FAMILY OF ICD DEVICES (P910023/S376) | ABBOTT MEDICAL | 2016-11-17 |
| Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT-D; Consulta CRT-D; InSync II Protect ICD; Maximo II CRT-D; Protecta X (P010031/S560) | Medtronic Cardiac Rhythm Disease Management | 2016-11-17 |
| PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA. (P030054/S313) | ABBOTT MEDICAL | 2016-11-17 |
| Consulta, Syncra, Viva CRT-P (P010015/S308) | Medtronic, Inc. | 2016-11-17 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S061) | ABBOTT MEDICAL | 2016-11-17 |
| CARDIOMEMS HF SYSTEM (P100045/S012) | ABBOTT MEDICAL | 2016-11-16 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATETER (P130024/S014) | Lutonix | 2016-11-14 |
| Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M (P980016/S607) | Medtronic Cardiac Rhythm Disease Management | 2016-11-14 |
| Revo MRI SureScan IPG RVDR01 (P090013/S239) | Medtronic, Inc. | 2016-11-10 |
| Advisa DR IPG A4DR01, Advisa DR MRI IPG A2DR01, Advisa SR MRI IPG A3SR01 (P980035/S479) | Medtronic, Inc. | 2016-11-10 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S065) | Edwards Lifesciences, LLC | 2016-11-10 |
| CLOSER VASCULAR SEALING SYSTEM (P150022/S002) | Rex Medical, L.P. | 2016-11-10 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATETER (P130024/S013) | Lutonix | 2016-11-09 |
| IsoFlex Optim Leads (P960030/S048) | ABBOTT MEDICAL | 2016-11-06 |
| QuickFlex and Quartet Leads (P030054/S312) | ABBOTT MEDICAL | 2016-11-06 |
| Durata and Optisure Leads (P950022/S096) | ABBOTT MEDICAL | 2016-11-06 |
| TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (P960013/S086) | ABBOTT MEDICAL | 2016-11-06 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA2 PACEMAKER MODELS (N970003/S196) | Boston Scientific Corp | 2016-11-03 |
| VALITUDE CRT-P (P030005/S144) | Guidant Corp. | 2016-11-03 |
| IMPELLA CP SYSTEM (P140003/S011) | Abiomed, Inc. | 2016-11-03 |
| LifeVest Device (P010030/S085) | Zoll Manufacturing Corporation | 2016-11-03 |
| ESSENTIO, PROPONENT, ACCOLADE MRI PACEMAKERS (P150012/S017) | Boston Scientific | 2016-11-03 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S069) | Medtronic, Inc. | 2016-11-02 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S084) | Medtronic | 2016-11-02 |
| ADHESIVE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS+ LEADS (P830061/S136) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| DF-1 CONNECTOR PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/SUBCUTANEOUS/TRANSVENCE CS/SVC LEADS (P920015/S186) | Medtronic, Inc. | 2016-11-02 |