| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S012) | Syncardia Systems, LLC | 2012-06-26 |
| S.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC) (P010041/S030) | Edwards Lifesciences, LLC | 2012-06-26 |
| ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S052) | Abiomed Cardiovascular, Inc. | 2012-06-26 |
| RX HECULINK ELITE RENAL STENT SYSTEM (P110001/S003) | Abbott Vascular | 2012-06-26 |
| PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDS (P010031/S311) | Medtronic Cardiac Rhythm Disease Management | 2012-06-25 |
| LIVIAN, PUNTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S293) | Boston Scientific Corp | 2012-06-25 |
| MEDTRONIC OPEN PIVOT BILEAFLET HEART VALVED (P990046/S029) | Medtronic Ats Medical, Inc. | 2012-06-25 |
| INVIVE CRT-P CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) (P030005/S084) | Guidant Corp. | 2012-06-25 |
| MEDTRONIC DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS (P980016/S358) | Medtronic Cardiac Rhythm Disease Management | 2012-06-25 |
| CONFIANT, PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S263) | Boston Scientific | 2012-06-25 |
| CONTAK CD FAMILY (INCLUDES RENEWAL FAMILY) (P010012/S069) | Boston Scientific Corp | 2012-06-22 |
| VENTAK AV FAMILY (INCLUDES PRIZM AND VITALITY FAMILIES) (P960040/S078) | Boston Scientific | 2012-06-22 |
| THORATEC HEART MATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S018) | ABBOTT MEDICAL | 2012-06-22 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S033) | Zoll Manufacturing Corporation | 2012-06-22 |
| ACCULINK, RX (P040012/S045) | Abbott Vascular | 2012-06-21 |
| XACT (P040038/S025) | Abbott Vascular, Inc. | 2012-06-21 |
| ABSOLUTE PRO, ABSOLUTE PRO LL (P110028/S003) | Abbott Vascular, Inc. | 2012-06-21 |
| HERCULINK ELITE, RX (P110001/S005) | Abbott Vascular | 2012-06-21 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S002) | Abbott Vascular, Inc. | 2012-06-20 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S115) | Boston Scientific Corp | 2012-06-20 |
| UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA (P030054/S222) | ABBOTT MEDICAL | 2012-06-20 |
| PUNCTUA CRT-D, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S291) | Boston Scientific Corp | 2012-06-19 |
| VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER (P910077/S121) | Boston Scientific | 2012-06-19 |
| PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D (P010031/S309) | Medtronic Cardiac Rhythm Disease Management | 2012-06-19 |
| PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD (P980016/S356) | Medtronic Cardiac Rhythm Disease Management | 2012-06-19 |
| PUNCTUA ICD, ENEGEN ICD, INCEPTA ICD (P960040/S261) | Boston Scientific | 2012-06-19 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S048) | Abbott Vascular | 2012-06-18 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S050) | Boston Scientific Corp | 2012-06-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (P870072/S048) | Thoratec Laboratories Corp. | 2012-06-18 |
| BARD E-LUMINEXXVASCULAR STENT (P080007/S014) | Bard Peripheral Vascular, Inc. | 2012-06-18 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S021) | Abbott Vascular | 2012-06-18 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S026) | Bard Peripheral Vascular | 2012-06-18 |
| THERMOCOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS (P030031/S039) | Biosense Webster, Inc. | 2012-06-15 |
| PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD (P980016/S355) | Medtronic Cardiac Rhythm Disease Management | 2012-06-15 |
| PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D (P010031/S308) | Medtronic Cardiac Rhythm Disease Management | 2012-06-15 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S163) | Medtronic, Inc. | 2012-06-14 |
| ADVISA DR IPG (P980035/S271) | Medtronic, Inc. | 2012-06-14 |
| FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES (P020045/S043) | Medtronic Cryocath, LP | 2012-06-14 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S002) | Medtronic Vascular, Inc. | 2012-06-14 |
| PROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S (P980016/S353) | Medtronic Cardiac Rhythm Disease Management | 2012-06-13 |
| PARADYM VR, DR RF VR & RF DR (P980049/S073) | MicroPort CRM USA, Inc. | 2012-06-11 |
| SECURA, MAXIMOII, PROTECTA, PROTECTA XT (P980016/S354) | Medtronic Cardiac Rhythm Disease Management | 2012-06-11 |
| CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT (P010031/S307) | Medtronic Cardiac Rhythm Disease Management | 2012-06-11 |
| REPLY SR AND DR, ESPRIT SR AND DR (P950029/S068) | MicroPort CRM USA, Inc. | 2012-06-11 |
| PARADYM CRT-D, RF CRT-D (P060027/S040) | MicroPort CRM USA, Inc. | 2012-06-11 |
| ON-X PROSTHETIC HEART VALVE (P000037/S025) | On-X Life Technologies, Inc. | 2012-06-08 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S019) | Abbott Vascular | 2012-06-07 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S001) | Abbott Vascular, Inc. | 2012-06-07 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S017) | Medtronic Vascular | 2012-06-07 |
| HERCULINK ELITE RENAL STENT SYSTEM (P110001/S004) | Abbott Vascular | 2012-06-07 |
| AMPLATZER SEPTAL AND CRIBRIFORM OCCLUDERS (P000039/S046) | ABBOTT MEDICAL | 2012-06-06 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S001) | Boston Scientific Corp | 2012-06-06 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S021) | ABBOTT MEDICAL | 2012-06-06 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S001) | Medtronic Vascular, Inc. | 2012-06-06 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S031) | Boston Scientific Corp | 2012-06-06 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S020) | Boston Scientific Corporation | 2012-06-06 |
| SELECTSECURE (P030036/S039) | Medtronic Cardiac Rhythm Disease Management | 2012-06-06 |
| AMPLATZER DUCT OCCLUDER (P020024/S036) | ABBOTT MEDICAL | 2012-06-06 |
| TAPSCOPE 550 (P860008/S021) | Cardio Command | 2012-06-05 |
| THORATEC HEARTMATE II LVAS (P060040/S015) | ABBOTT MEDICAL | 2012-06-05 |
| THORATEC HEARTMATE II LVAS (P060040/S021) | ABBOTT MEDICAL | 2012-06-05 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S157) | Medtronic, Inc. | 2012-06-04 |
| ADVISA DR IPG (P980035/S264) | Medtronic, Inc. | 2012-06-04 |
| CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D/DF4, PROTECTA CRT-D/DF4/XT CRT-D/XT DF4 (P010031/S306) | Medtronic Cardiac Rhythm Disease Management | 2012-06-04 |
| CONCERT II, CONSULTA, & MAXIMO II CRT-DS (P010031/S296) | Medtronic Cardiac Rhythm Disease Management | 2012-06-04 |
| INCEPTA, ENERGEN AND PUNTUA ICD DEVICES (P960040/S260) | Boston Scientific | 2012-06-04 |
| CARELINK DEVICE DATA MANAGEMENT APPLICATION (MODEL 2491) (P890003/S247) | Medtronic, Inc. | 2012-06-04 |
| MAXIMO II DF4/ICD, PROTECTA DF4/ICD/XT DF4/XT ICD, SECURA DF4/ ICD & VIRTUOSO II DR/VR ICD (P980016/S352) | Medtronic Cardiac Rhythm Disease Management | 2012-06-04 |
| INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S290) | Boston Scientific Corp | 2012-06-04 |
| MAXIMO II, SECURA & VIRTUOSO II DR/VR ICDS (P980016/S343) | Medtronic Cardiac Rhythm Disease Management | 2012-06-04 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S028) | W. L. Gore & Associates, Inc. | 2012-06-01 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S037) | Endologix, LLC | 2012-06-01 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S001) | Boston Scientific Corp | 2012-06-01 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S071) | Abbott Vascular, Inc. | 2012-05-31 |
| THORATEC HEARTMATE II VAS (P060040/S020) | ABBOTT MEDICAL | 2012-05-31 |
| VERIFLEX MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM (P040016/S088) | Boston Scientific Scimed, Inc. | 2012-05-30 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S028) | Boston Scientific Corp | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S089) | Edwards Lifesciences, LLC | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P870056/S049) | Edwards Lifesciences, LLC | 2012-05-30 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S043) | Boston Scientific Corp | 2012-05-30 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S073) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S038) | Spectranetics (Philips) | 2012-05-30 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S027) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S028) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S014) | Boston Scientific Corp | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P010041/S033) | Edwards Lifesciences, LLC | 2012-05-30 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S043) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S048) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P000007/S031) | Edwards Lifesciences, LLC | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P870077/S044) | Edwards Lifesciences, LLC | 2012-05-30 |
| EXPRESS MONORAIL OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S085) | Boston Scientific Scimed, Inc. | 2012-05-30 |
| PARADYM RF CRT-D (P060027/S041) | MicroPort CRM USA, Inc. | 2012-05-30 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S055) | Spectranetics Corp. | 2012-05-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S010) | Edwards Lifesciences, LLC | 2012-05-30 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S042) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| PARADYM RF VR & RF DR ICD (P980049/S074) | MicroPort CRM USA, Inc. | 2012-05-30 |
| MULTI-LINK VISION CORONARY STENT SYSTEMS (P020047/S041) | Abbott Vascular | 2012-05-25 |
| LIFESTENT SOLO VASCULAR STENT SYSTEM (P070014/S032) | Bard Peripheral Vascular, Inc. | 2012-05-25 |
| MULTI-LINK CORONARY STENT SYSTEMS (P970020/S070) | Abbott Vascular, Inc. | 2012-05-25 |
| TMR2000 HOLMIUM LASER SYSTEM (P970029/S019) | Cryolife, Inc. | 2012-05-25 |