| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S062) | Edwards Lifesciences, LLC | 2016-08-19 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S131) | Boston Scientific Corp | 2016-08-19 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF - PM3120, PM3222, PM3140, PM3242 (P030035/S148) | ABBOTT MEDICAL | 2016-08-19 |
| CHILLI II (P980003/S069) | Boston Scientific Corp | 2016-08-19 |
| Assurity - PM1240, PM2240, Assurity+ - PM1260, PM2260, Endurity - PM1160, PM2160, Endurity Core - PM1152, PM2152 (P880086/S274) | ABBOTT MEDICAL | 2016-08-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S015) | Edwards Lifesciences, LLC | 2016-08-19 |
| BLAZER OI; INTELLANAV OI (P150005/S010) | Boston Scientific Corp | 2016-08-19 |
| Emblem SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S060) | Boston Scientific Corporation | 2016-08-19 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S018) | Boston Scientific Corporation | 2016-08-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S057) | Edwards Lifesciences, LLC | 2016-08-18 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S010) | Edwards Lifesciences, LLC | 2016-08-18 |
| ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SET'S (P980037/S058) | Boston Scientific Corp | 2016-08-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S017) | Boston Scientific Corporation | 2016-08-18 |
| WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE) (P950020/S072) | Boston Scientific Corp | 2016-08-18 |
| GORE VIATORR TIPS (P040027/S048) | W. L. Gore & Associates, Inc. | 2016-08-18 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S130) | Boston Scientific Corp | 2016-08-18 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S086) | W. L. Gore & Associates, Inc. | 2016-08-18 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S078) | Medtronic | 2016-08-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S006) | Boston Scientific Corporation | 2016-08-17 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM (P120006/S025) | Endologix, LLC | 2016-08-17 |
| Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ (P010031/S558) | Medtronic Cardiac Rhythm Disease Management | 2016-08-16 |
| Revo MRI SureScan IPG RVDR01 (P090013/S232) | Medtronic, Inc. | 2016-08-16 |
| Micra TPS MC1VR01 (P150033/S005) | Medtronic, Inc. | 2016-08-16 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S597) | Medtronic Cardiac Rhythm Disease Management | 2016-08-16 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S472) | Medtronic, Inc. | 2016-08-16 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 (P010015/S306) | Medtronic, Inc. | 2016-08-16 |
| SELECTSECURE LEAD (P030036/S086) | Medtronic Cardiac Rhythm Disease Management | 2016-08-15 |
| MICRA TRANSCATHETER PACING SYSTEM (P150033/S006) | Medtronic, Inc. | 2016-08-15 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036) | Edwards Lifesciences, LLC | 2016-08-12 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S090) | Boston Scientific | 2016-08-11 |
| THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE (P030031/S072) | Biosense Webster, Inc. | 2016-08-11 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S077) | Boston Scientific Corp | 2016-08-11 |
| INGEVITY ACTIVE FIXATION LEAD (P150012/S012) | Boston Scientific | 2016-08-11 |
| EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM (P090003/S042) | Boston Scientific Corporation | 2016-08-11 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S094) | Boston Scientific Corp | 2016-08-11 |
| BLAZER OPEN-IRRIGATED TEMPERATURE ABLATION CATHETER (P150005/S009) | Boston Scientific Corp | 2016-08-11 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S075) | Boston Scientific Corp | 2016-08-11 |
| CHILLI COOLED ABLATION CATHETER AND CABLE (P980003/S068) | Boston Scientific Corp | 2016-08-11 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S036) | Boston Scientific Corp | 2016-08-11 |
| MEDTRONIC CARELINK ENCORE 29901 PROGRAMMER (P890003/S360) | Medtronic, Inc. | 2016-08-11 |
| MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM SFA and PPA (P110040/S010) | Medtronic Vascular | 2016-08-10 |
| MYCARELINK PATIENT MONITOR, MYCARELINK READER FIELD REPLACEMENT UNIT (FRU), MYCARELINK SMART PATIENT READER, CARELINK EN (P890003/S362) | Medtronic, Inc. | 2016-08-10 |
| VALIANT THORACIC STENT GRAFT SYSTEM W/ the Captivia Delivery System (P100040/S027) | Medtronic Vascular | 2016-08-10 |
| SYNERGY EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P150003/S016) | Boston Scientific Corporation | 2016-08-10 |
| RESOLUTE INTEGRITY CORONARY STENT SYSTEM (P110013/S074) | Medtronic Vascular | 2016-08-10 |
| MEDTRONIC COREVALVE SYSTEM and Medtronic CoreValve Evolut R System (P130021/S023) | Medtronic, Inc. | 2016-08-10 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM Monorail & OTW (P130030/S025) | Boston Scientific Corp | 2016-08-10 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S025) | Boston Scientific Corp | 2016-08-10 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S026) | Boston Scientific Corp | 2016-08-10 |
| COMPLETE SE VASCULAR STENT SYSTEM Iliac (P090006/S018) | Medtronic Vascular | 2016-08-10 |
| VALITUDE CRT-P, ACCOLADE CRT-P (P030005/S140) | Guidant Corp. | 2016-08-10 |
| MEDTRONIC ENDURANT STENT GRAFT SYSTEM (P100021/S055) | Medtronic Vascular | 2016-08-10 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S076) | Boston Scientific Corp | 2016-08-10 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S129) | Boston Scientific Corp | 2016-08-10 |
| Integrity CORONARY STENT SYSTEMS (P030009/S088) | Medtronic, Ireland | 2016-08-10 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S012) | Medtronic, Ireland | 2016-08-10 |
| ROTABLATOR Rotational Atherectomy System (P900056/S154) | Boston Scientific Corp | 2016-08-10 |
| TALENT Occluder W Occluder Delivery System (P070027/S047) | Medtronic Vascular | 2016-08-10 |
| IN PACT ADMIRAL PACLITAXEL-Coated PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S021) | Medtronic, Inc. | 2016-08-10 |
| ALTRUA, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S192) | Boston Scientific Corp | 2016-08-10 |
| EXPRESS 2 MR & OTW (P020009/S128) | Boston Scientific Scimed, Inc. | 2016-08-10 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S128) | Boston Scientific Corp | 2016-08-10 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S015) | Boston Scientific Corporation | 2016-08-09 |
| PLATINIUM CRT-D 1711/1741 (P060027/S081) | MicroPort CRM USA, Inc. | 2016-08-09 |
| PLATINIUM VR 1210/1240, PLATINIUM DR 1510/1540 (ICD) (P980049/S115) | MicroPort CRM USA, Inc. | 2016-08-09 |
| Impella Ventricular Support Systems (P140003/S010) | Abiomed, Inc. | 2016-08-09 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S018) | ABBOTT MEDICAL | 2016-08-09 |
| IMPELLA VENTRICULAR SUPPORT SYSTEMS (P140003/S009) | Abiomed, Inc. | 2016-08-09 |
| Platinium CRT-D 1711; Platinium CRT-D 1741 (P060027/S082) | MicroPort CRM USA, Inc. | 2016-08-08 |
| Platinium VR 1210; Platinium VR 1240; Platinium DR 1510; Platinium DR 1540 (P980049/S116) | MicroPort CRM USA, Inc. | 2016-08-08 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S058) | Boston Scientific Corporation | 2016-08-08 |
| GEM II DR/GEM II VR/GEM III DR/GEM III VR/ENTRUST/INTRINSIC 30/INTRINSIC/MARQUIS DR/MARQUIS VR/MAXIMO II DR/MAXIMO II/MA (P980016/S592) | Medtronic Cardiac Rhythm Disease Management | 2016-08-07 |
| CONCERTO/CONCERTO II/CONSULTA DF4/CONSULTA/INSYNC II PROTECT/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/INSYNC II MA (P010031/S553) | Medtronic Cardiac Rhythm Disease Management | 2016-08-07 |
| GEM III AT ICD (P980050/S104) | Medtronic, Inc. | 2016-08-07 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S029) | ABBOTT MEDICAL | 2016-08-04 |
| IN.PACT ADMIRAL PACLITAXEL-COATED BALLOON CATHETER (P140010/S022) | Medtronic, Inc. | 2016-08-04 |
| AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II (P020024/S046) | ABBOTT MEDICAL | 2016-08-04 |
| AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S056) | ABBOTT MEDICAL | 2016-08-04 |
| SMARTABLATE SYSTEM: SMARTABLATE RF GENERATOR AND REMOTE CONTROL, SMARTABLATE SYSTEM: SMARTABLATE IRRIGATION PUMP (P990071/S033) | Biosense Webster, Inc. | 2016-08-04 |
| OPEN PIVOT HEART VALVE & OPEN PIVOT AORTIC VALVED GRAFT (P990046/S047) | Medtronic Ats Medical, Inc. | 2016-08-04 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S009) | Boston Scientific Corp | 2016-08-04 |
| LIFEVEST WEARABLE DEFIBRILLATOR (WCD) 4000 (P010030/S079) | Zoll Manufacturing Corporation | 2016-08-03 |
| TACTICATH QUARTZ SET (P130026/S021) | St Jude Medical | 2016-08-03 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S064) | St Jude Medical | 2016-08-02 |
| ENDOTAK RELIANCE 4-SITE LEADS PASSIVE FIXATION & ENDOTAK RELIANCE 4-SITE ACTIVE FIXATION (P910073/S137) | Boston Scientific | 2016-08-02 |
| DYNAGEN, INOGEN, ORIGEN ICD'S (P960040/S377) | Boston Scientific | 2016-08-02 |
| ESSENTIO, PROPONENT, ACCOLADE,ALTRUA 2 PACEMAKER'S (N970003/S191) | Boston Scientific Corp | 2016-08-02 |
| EMBLEM S-ICD SYSTEM (P110042/S061) | Boston Scientific Corporation | 2016-08-02 |
| ACUITY X4 STRAIGHT, SPIRAL, SPIRAL L ; DYNAGEN, INOGEN, ORIGEN CRT-D'S (P010012/S428) | Boston Scientific Corp | 2016-08-02 |
| VALITUDE CRT-P (P030005/S139) | Guidant Corp. | 2016-08-02 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S061) | Edwards Lifesciences, LLC | 2016-08-02 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI PACEMAKER'S (P150012/S011) | Boston Scientific | 2016-08-02 |
| FINELINE II (P960004/S077) | Boston Scientific | 2016-08-02 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM ,EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM (P110023/S020) | Medtronic Vascular, Inc. | 2016-08-02 |
| SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021/S028) | ABBOTT MEDICAL | 2016-08-01 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S020) | Cardiva Medical, Inc. | 2016-08-01 |
| DYNAGEN CRT-D: G150, G151, G154; DYNAGEN X4 CRT-D: G156, G158; INOGEN CRT-D: G140, G141; INOGEN X4 CRT-D: G146, G148 (P010012/S429) | Boston Scientific Corp | 2016-08-01 |
| QUARTET CRT LEADS (P030054/S308) | ABBOTT MEDICAL | 2016-08-01 |
| PROMRI ICD/CRT-D SYSTEM (P050023/S100) | Biotronik, Inc. | 2016-08-01 |
| DYNAGEN EL ICD: D150, D151, D152, D153; INOGEN EL ICD: D140, D141, D142, D143; ORIGEN EL ICD: D050, D051, D052, D053; (P960040/S378) | Boston Scientific | 2016-08-01 |