| PARADYM VR & DR (P980049/S070) | MicroPort CRM USA, Inc. | 2012-02-16 |
| PARADYM CRT-D (P060027/S037) | MicroPort CRM USA, Inc. | 2012-02-16 |
| CONTAK RENEWAL TR, CONTAK RENEWAL 3, LEVIAN SE/HE, COGNIS, INCEPTA (P010012/S280) | Boston Scientific Corp | 2012-02-16 |
| STELID II BFT/BJF/STELIX BR/STELIX II BRF (P020030/S009) | MicroPort CRM USA, Inc. | 2012-02-16 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S084) | Boston Scientific Corp | 2012-02-15 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S034) | Boston Scientific Corp | 2012-02-15 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S070) | Terumo Medical Corporation | 2012-02-15 |
| CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP (P980003/S034) | Boston Scientific Corp | 2012-02-15 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S036) | Endologix, LLC | 2012-02-15 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S039) | Cordis US Corporation | 2012-02-13 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S014) | Medtronic Cryocath, LP | 2012-02-09 |
| CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE 4MM TIP CATHETERS/CELSIUS RMT DIAGNOSTIC/ABLATION STEERABLE TIP (P950005/S033) | Biosense Webster, Inc. | 2012-02-08 |
| NAVISTAR, CELSIUS, QWIKSTAR, EZ STEER BI-DIRECTIONAL, NAVISTAR RMT DUAL SENOR (8MM) DIAGNOSTIC/ABLATION DEFLECTABLE (P010068/S023) | Biosense Webster, Inc. | 2012-02-08 |
| S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM FOR USE IN LLIAC ARTERIES (P020036/S022) | Cordis US Corporation | 2012-02-06 |
| TRIFECA VALVE (P100029/S010) | ABBOTT MEDICAL | 2012-02-06 |
| GORE VIABAHN ENDOPROSTHESIS & ENDOPROSTHESIS WITH HERPARIN BIOACTIVE SURFACE (P040037/S041) | W. L. Gore & Associates, Inc. | 2012-02-06 |
| GORE VIABAHN ENDOPROSTHESIS & ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S040) | W. L. Gore & Associates, Inc. | 2012-02-06 |
| PRECISE OTW/PRECISE RX & PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S023) | Cordis US Corporation | 2012-02-06 |
| ETHICON OMNEX SURGICAL SEALANT (P060029/S003) | ETHICON, Inc. | 2012-02-03 |
| REPLY/ESPRIT (P950029/S065) | MicroPort CRM USA, Inc. | 2012-02-02 |
| PARADYM VR & DR (P980049/S069) | MicroPort CRM USA, Inc. | 2012-02-02 |
| ANTHEM CRT-P DEVICES (P030035/S093) | ABBOTT MEDICAL | 2012-02-02 |
| PARADYM CRT-D (P060027/S036) | MicroPort CRM USA, Inc. | 2012-02-02 |
| ACCENT PACEMAKER DEVICES (P880086/S215) | ABBOTT MEDICAL | 2012-02-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S001) | Edwards Lifesciences, LLC | 2012-01-31 |
| CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S008) | Boston Scientific Corp | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082) | Cordis Corp. | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085) | Cordis Corp. | 2012-01-26 |
| TELIGEN/INCEPTA/ENERGEN/PUNCTUA/CONFIENT ICDS (P960040/S250) | Boston Scientific | 2012-01-26 |
| COGNIS/INCEPTA/ENERGEN/PUNCTUA/LIVIAN CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (P010012/S278) | Boston Scientific Corp | 2012-01-26 |
| COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S277) | Boston Scientific Corp | 2012-01-25 |
| TELIGEN/INCEPTA/ENERGEN/PUNCTUA ICDS (P960040/S249) | Boston Scientific | 2012-01-25 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S032) | Boston Scientific Corp | 2012-01-25 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016) | ABBOTT MEDICAL | 2012-01-25 |
| XIENCE V & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S085) | Abbott Vascular, Inc. | 2012-01-20 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S031) | Boston Scientific Corp | 2012-01-20 |
| XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S008) | Abbott Vascular | 2012-01-20 |
| TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S248) | Boston Scientific | 2012-01-19 |
| COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S276) | Boston Scientific Corp | 2012-01-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S003) | Edwards Lifesciences, LLC | 2012-01-19 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSUR MITRAL BIOPROSTHESIS (P870077/S041) | Edwards Lifesciences, LLC | 2012-01-19 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S028) | Edwards Lifesciences, LLC | 2012-01-19 |
| CARPENTIER-EDWARDS BIOPROSTHESES (P870056/S045) | Edwards Lifesciences, LLC | 2012-01-19 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S082) | Edwards Lifesciences, LLC | 2012-01-19 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S029) | Edwards Lifesciences, LLC | 2012-01-19 |
| REVO MRI (P090013/S049) | Medtronic, Inc. | 2012-01-18 |
| DEMA IPG/C & T SERIES IPGS (P990001/S099) | Medtronic, Inc. | 2012-01-18 |
| KAPPA 700/800/900/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA/RELIA/ADVISA DR IPGS (P980035/S255) | Medtronic, Inc. | 2012-01-18 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S016) | Medtronic Vascular, Inc. | 2012-01-18 |
| XIENCE PRIME/XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S006) | Abbott Vascular | 2012-01-18 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S023) | Bard Peripheral Vascular | 2012-01-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S004) | Edwards Lifesciences, LLC | 2012-01-18 |
| INSYNC/INSYNC III/CONSULTA/SYNERA CRT-PS (P010015/S151) | Medtronic, Inc. | 2012-01-18 |
| KAPPA 400 DR/SR IPG (P970012/S090) | Medtronic, Inc. | 2012-01-18 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S083) | Edwards Lifesciences, LLC | 2012-01-18 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/VIRTUOSO II/SECURA/PROTECTA XT/PROTECTA/PROTECTA XT/PROTECTA DF4 ICD (P980016/S333) | Medtronic Cardiac Rhythm Disease Management | 2012-01-18 |
| PRODOGY (P890003/S243) | Medtronic, Inc. | 2012-01-18 |
| XIENCE PRME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S007) | Abbott Vascular | 2012-01-18 |
| INSYNC/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA/PROTECTA XT/PROTECTA/PROTECTA DF4 (P010031/S286) | Medtronic Cardiac Rhythm Disease Management | 2012-01-18 |
| COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (P010012/S275) | Boston Scientific Corp | 2012-01-13 |
| SPECTRANETICS LASER SHEATHS (SLS) (P960042/S029) | Spectranetics (Philips) | 2012-01-13 |
| FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S041) | Medtronic Cryocath, LP | 2012-01-13 |
| PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S003) | Boston Scientific Corp | 2012-01-13 |
| GORE EXCLUDER AAA ENDOPROSTHESIS CATHETER (P020004/S068) | W. L. Gore & Associates, Inc. | 2012-01-13 |
| TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S247) | Boston Scientific | 2012-01-13 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER (P100010/S013) | Medtronic Cryocath, LP | 2012-01-13 |
| NAVISTAR RMT THERMOCOOL CATHETER (P040036/S024) | Biosense Webster, Inc. | 2012-01-13 |
| NAVISTAR RMT THERMOCOOL CATHETER (P030031/S033) | Biosense Webster, Inc. | 2012-01-13 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S047) | Spectranetics Corp. | 2012-01-13 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S040) | W. L. Gore & Associates, Inc. | 2012-01-13 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (6F/7F) (P040044/S040) | Cordis US Corporation | 2012-01-13 |
| PARADYM VR/DR (P980049/S068) | MicroPort CRM USA, Inc. | 2012-01-11 |
| PARADYM CRT (P060027/S035) | MicroPort CRM USA, Inc. | 2012-01-11 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S008) | LeMaitre Vascular, Inc. | 2012-01-10 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S043) | ABBOTT MEDICAL | 2012-01-10 |
| MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P010031/S176) | Medtronic Cardiac Rhythm Disease Management | 2012-01-09 |
| MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M (P920015/S055) | Medtronic, Inc. | 2012-01-09 |
| CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE (P890003/S179) | Medtronic, Inc. | 2012-01-09 |
| MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S216) | Medtronic Cardiac Rhythm Disease Management | 2012-01-09 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S042) | Cordis US Corporation | 2012-01-06 |
| VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS (P020047/S036) | Abbott Vascular | 2012-01-06 |
| MULTILINK ZETA/PIXEL & ULTRA CORONARY STENT SYSTEMS (P970020/S065) | Abbott Vascular, Inc. | 2012-01-06 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S012) | Medtronic Vascular | 2012-01-06 |
| XIENCE V & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S075) | Abbott Vascular, Inc. | 2012-01-06 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S039) | Abbott Vascular | 2012-01-06 |
| ENDOTAK RELIANCE IS-I PASSIVE FIXATION (P910073/S091) | Boston Scientific | 2012-01-05 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S002) | Abbott Vascular | 2012-01-04 |
| FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS (P030035/S091) | ABBOTT MEDICAL | 2011-12-30 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S005) | Abbott Vascular | 2011-12-30 |
| ST JUDE MEDICAL ICDS/CRT-DS AND LEADS (P030054/S209) | ABBOTT MEDICAL | 2011-12-30 |
| ST JUDE MEDICAL ICDS/CRT-DS AND LEADS (P910023/S282) | ABBOTT MEDICAL | 2011-12-30 |
| AFFINITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S213) | ABBOTT MEDICAL | 2011-12-30 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S052) | Spectranetics Corp. | 2011-12-27 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S033) | Spectranetics (Philips) | 2011-12-27 |
| CONCERTO/CONCERTO II, CONSULTA, MAXIMO II, PROTECTA/PROTECTA XT (P010031/S285) | Medtronic Cardiac Rhythm Disease Management | 2011-12-23 |
| ENTRUST, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO/VIRTUOSO II (P980016/S332) | Medtronic Cardiac Rhythm Disease Management | 2011-12-23 |
| CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES (P950005/S036) | Biosense Webster, Inc. | 2011-12-23 |
| OVAL PATCH LEAD (P900061/S109) | Medtronic Cardiac Rhythm Disease Management | 2011-12-23 |
| LEAD TERMINAL CAP (P940008/S028) | Boston Scientific | 2011-12-23 |
| ADVISA (P980035/S254) | Medtronic, Inc. | 2011-12-23 |