| ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES (P030035/S144) | ABBOTT MEDICAL | 2016-01-04 |
| PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S091) | Abbott Vascular, Inc. | 2015-12-31 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CATHETER (P020045/S069) | Medtronic Cryocath, LP | 2015-12-31 |
| CARDIOGENESIS TMR SYSTEM (P970029/S028) | Cryolife, Inc. | 2015-12-22 |
| TACTICATH QUARTZ SET (P130026/S013) | St Jude Medical | 2015-12-22 |
| NOVAFLEX+ DELIVERY SYSTEM (P130009/S043) | Edwards Lifesciences, LLC | 2015-12-21 |
| IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4) (P050023/S087) | Biotronik, Inc. | 2015-12-21 |
| FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) ; FLEXABILITY ABLATION CATHETER(UNI-DIRECTIONAL) (P110016/S028) | ABBOTT MEDICAL | 2015-12-21 |
| PROGRAMMER SOFTWARE(1503.U) FOR ICS 3000/RENAMIC PROGRAMMERS (P000009/S063) | Biotronik, Inc. | 2015-12-21 |
| PROGRAMMER SOFTWARE (1503.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS (P070008/S063) | Biotronik, Inc. | 2015-12-21 |
| LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D (P980023/S072) | Biotronik, Inc. | 2015-12-21 |
| LINOX SMART(S65)(SD65/18)(SDX65/15&65/17),PROTEGO DF-1(S65)(SD65/18)(DX65/15&65/17),PROTEGO(S65&75)(SD65/16,65/18,75/18) (P950037/S151) | Biotronik, Inc. | 2015-12-21 |
| ORIGEN, INOGEN, AND DYNAGEN ICD, INCEPTA, ENERGEN, AND PUNCTUA ICD, TELIGEN ICD (P960040/S360) | Boston Scientific | 2015-12-21 |
| ORIGEN, INOGEN, AND DYNAGEN CRT-D, INCEPTA ENERGEN PUNCTUA CRT-D, COGNIS CRT-D (P010012/S405) | Boston Scientific Corp | 2015-12-21 |
| BIOTRONIK ICD FAMILIES (P050023/S090) | Biotronik, Inc. | 2015-12-18 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S054) | Boston Scientific Corp | 2015-12-18 |
| ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL) (P910001/S082) | Spectranetics Corp. | 2015-12-18 |
| ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM (P140030) | Biotronik AG | 2015-12-17 |
| CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH (P030031/S059) | Biosense Webster, Inc. | 2015-12-17 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S056) | Zoll Manufacturing Corporation | 2015-12-17 |
| BIOSENSE WEBSTER CABLES (P990071/S028) | Biosense Webster, Inc. | 2015-12-17 |
| BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS RMT CATHETER, CLESIUS FLTR, DEFLECTABLE DISGNOSTIC/ABLATION CATHETER (P950005/S051) | Biosense Webster, Inc. | 2015-12-17 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S022) | Boston Scientific Corp | 2015-12-17 |
| EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH (P040036/S044) | Biosense Webster, Inc. | 2015-12-17 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM (P110023/S016) | Medtronic Vascular, Inc. | 2015-12-17 |
| BLAZER PRIME HTD, BLAZER II, BLAZER II HTD (P920047/S087) | Boston Scientific Corp | 2015-12-17 |
| BLAZER II XP, BLAZER PRIME XP AND INTELLA TIP MIFI XP (P020025/S081) | Boston Scientific | 2015-12-17 |
| BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH (P010068/S040) | Biosense Webster, Inc. | 2015-12-17 |
| BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NAVISTAR CATHETER, NAVISTAR RMT CATHETER (P990025/S040) | Biosense Webster, Inc. | 2015-12-17 |
| OPEN PIVOT AORTIC VALVED GRAFT (P990046/S043) | Medtronic Ats Medical, Inc. | 2015-12-16 |
| CAPSUREFIX MRI LEAD (P090013/S210) | Medtronic, Inc. | 2015-12-16 |
| CAPSURE SENSE LEAD (P830061/S124) | Medtronic Cardiac Rhythm Disease Management | 2015-12-16 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S448) | Medtronic, Inc. | 2015-12-16 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S078) | W. L. Gore & Associates, Inc. | 2015-12-16 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S012) | Abbott Vascular (Idef Technologies Inc) | 2015-12-16 |
| CAPSUREFIX NOVUS LEAD (P930039/S144) | Medtronic, Inc. | 2015-12-16 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S124) | W. L. Gore & Associates, Inc. | 2015-12-16 |
| OPEN PIVOT HEART VALVE,OPEN PIVOT AORTIC VALVED GRAFT,OPEN PIVOT HEART VALVE-APEX,OPEN PIVOT HEART VALVE-AP360 (P990046/S044) | Medtronic Ats Medical, Inc. | 2015-12-16 |
| CAROTID WALLSTENT MONORAIL STENT SYSTEM (P050019/S023) | Boston Scientific Corp | 2015-12-16 |
| ANTHEM, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES (P030035/S143) | ABBOTT MEDICAL | 2015-12-15 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES (P910023/S366) | ABBOTT MEDICAL | 2015-12-15 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S046) | W. L. Gore & Associates, Inc. | 2015-12-15 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S069) | Medtronic | 2015-12-15 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKERS DEVICES (P880086/S265) | ABBOTT MEDICAL | 2015-12-15 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S296) | ABBOTT MEDICAL | 2015-12-15 |
| PROTEGE GPS STENT SYSTEM (P060001/S024) | Medtronic Vascular, Inc. | 2015-12-14 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY (P980037/S046) | Boston Scientific Corp | 2015-12-14 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S018) | Cardiva Medical, Inc. | 2015-12-14 |
| ANGIOJET XMI THROMBECTOMY SET, ANGIOJET SPIROFLEX THROMBECTOMY SET, ANGIOJEET SPIROFLEX VG THROMBECTOMY SET, ANGIOJET DI (P980037/S053) | Boston Scientific Corp | 2015-12-11 |
| ASCENDRA+ DELIVERY SYSTEM, NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET CRIMPER, QUALCRIMP CRIMPI (P130009/S042) | Edwards Lifesciences, LLC | 2015-12-11 |
| FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) , FLEXABILITY ABLATION CATHETER (UNI-DIRECTIONAL) (P110016/S026) | ABBOTT MEDICAL | 2015-12-11 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S066) | Medtronic | 2015-12-10 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY (P980037/S052) | Boston Scientific Corp | 2015-12-09 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S071) | Zoll Manufacturing Corporation | 2015-12-09 |
| SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) (P110042/S056) | Boston Scientific Corporation | 2015-12-09 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S049) | Bard Peripheral Vascular, Inc. | 2015-12-09 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S036) | Syncardia Systems, LLC | 2015-12-09 |
| VIVA, BRAVA, PROTECTA XT, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II, INSYNC II PROTECT (P010031/S520) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| ADAPTA, VERSA, SENSIA, ADVISA, ADVISA MRI, ENPULSE, KAPPA IPGS (P980035/S446) | Medtronic, Inc. | 2015-12-08 |
| MY CARELINK PATIENT MONITOR MODEL 24950 (P890003/S341) | Medtronic, Inc. | 2015-12-08 |
| CAPSURE SENSE LEAD, VITATRON CRYSTALLINE LEAD (P830061/S123) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| REVO MRI, SURESCAN IPG (P090013/S207) | Medtronic, Inc. | 2015-12-08 |
| EVERA MRI ICD, MARQUIS, SECURA, MAXIMO II, INTRINSIC,PROTECTA, PROTECTA XT, VIRTUOSO II (P980016/S558) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| REVO MRI, SURESCAN IPG (P090013/S206) | Medtronic, Inc. | 2015-12-08 |
| MEDTRONIC MYCARELINK PATIENT MONITOR MODEL 24950 (P890003/S342) | Medtronic, Inc. | 2015-12-08 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S443) | Medtronic, Inc. | 2015-12-08 |
| EVERA MRI ICD, S DR, XT DR ICD, XT VR ICD, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT IC (P980016/S556) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S285) | Medtronic, Inc. | 2015-12-08 |
| BRAVA CRT-D, QUAD CRT-D, CONCERTO OCD,CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, MAXIMO II CRT-D, PROTECT (P010031/S517) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S283) | Medtronic, Inc. | 2015-12-08 |
| DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D (P010012/S404) | Boston Scientific Corp | 2015-12-07 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S028) | Edwards Lifesciences, LLC | 2015-12-07 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES (P880086/S264) | ABBOTT MEDICAL | 2015-12-07 |
| ANTHEM,ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES (P030035/S142) | ABBOTT MEDICAL | 2015-12-07 |
| DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S359) | Boston Scientific | 2015-12-07 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S065) | Edwards Lifesciences, LLC | 2015-12-07 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S052) | Edwards Lifesciences, LLC | 2015-12-07 |
| ANTHEM, ALLURE/RF, ALLURA QUADRA/RF FAMILY OF CRT-P'S (P030035/S140) | ABBOTT MEDICAL | 2015-12-06 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S262) | ABBOTT MEDICAL | 2015-12-06 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+FAMILY OF ICDS (P910023/S364) | ABBOTT MEDICAL | 2015-12-06 |
| PROMOTE/+RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+HF, (P030054/S294) | ABBOTT MEDICAL | 2015-12-06 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL BALLOON CATHETER (P140010/S009) | Medtronic, Inc. | 2015-12-04 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S117) | Boston Scientific Corp | 2015-12-03 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP) (P040044/S066) | Cordis US Corporation | 2015-12-03 |
| SLS II AND GLIDELIGHT LASER SHEATH KITS (P960042/S052) | Spectranetics (Philips) | 2015-12-03 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S001) | Boston Scientific Corporation | 2015-12-03 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S068) | Medtronic | 2015-12-03 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S069) | Zoll Manufacturing Corporation | 2015-12-03 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S081) | Spectranetics Corp. | 2015-12-03 |
| GORE VIABAHN ENDOPROSTHESIS; GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S087) | W. L. Gore & Associates, Inc. | 2015-12-02 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S057) | Endologix, LLC | 2015-12-02 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOAVTIVE SURFACE (P130006/S026) | W. L. Gore & Associates, Inc. | 2015-12-02 |
| TACTICATH QUARTZ SET (P130026/S005) | St Jude Medical | 2015-12-02 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S086) | W. L. Gore & Associates, Inc. | 2015-12-02 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S025) | W. L. Gore & Associates, Inc. | 2015-12-02 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMOBECTOMY SET (P980037/S051) | Boston Scientific Corp | 2015-12-02 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S032) | Boston Scientific Corp | 2015-11-30 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S007) | Cardiovascular Systems, Inc. | 2015-11-30 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S006) | Boston Scientific Corporation | 2015-11-30 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S032) | Syncardia Systems, LLC | 2015-11-27 |