| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S091) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S052) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S037) | Zoll Manufacturing Corporation | 2012-12-20 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SURFIX LEAD, TORQUE CLIP DEVICE -ACCESSORY FOR 5076 LEAD, VITATRON CRYSTALLINE L (P930039/S078) | Medtronic, Inc. | 2012-12-20 |
| CAPSURE EPICARDIAL PACKING LEAD (P950024/S046) | Medtronic, Inc. | 2012-12-20 |
| TRANSVENE LEAD (P980050/S079) | Medtronic, Inc. | 2012-12-20 |
| ACUITY SPIRAL AND EASYTRAK 3 IS-1 LEADS (P010012/S315) | Boston Scientific Corp | 2012-12-20 |
| ACUITY STEERABLE LEAD FAMILY (P050046/S019) | Guidant Corp. | 2012-12-20 |
| ADAPTA, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG (P980035/S301) | Medtronic, Inc. | 2012-12-20 |
| ATTAIN STARFIX LEAD (P060039/S039) | Medtronic, Inc. | 2012-12-20 |
| Y ADAPTOR /EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO (P920015/S100) | Medtronic, Inc. | 2012-12-20 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S044) | Medtronic, Inc. | 2012-12-19 |
| SELECTSECURE LEAD (P030036/S051) | Medtronic Cardiac Rhythm Disease Management | 2012-12-19 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD (P920015/S098) | Medtronic, Inc. | 2012-12-19 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S036) | Medtronic, Inc. | 2012-12-19 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S017) | Medtronic, Inc. | 2012-12-19 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S050) | Abbott Vascular | 2012-12-19 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S033) | Medtronic Heart Valves | 2012-12-19 |
| MERLIN NET 6.1M (P030054/S237) | ABBOTT MEDICAL | 2012-12-19 |
| EVIA DR, EVIA SR, ENTOVIS DR, ENTOVIS SR, ESTELLA DR, ESTELLA SR, EFFECTA D, EFFECTA DR, EFFECTA S, EFFECTA SR, ECURO DR (P950037/S114) | Biotronik, Inc. | 2012-12-19 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S047) | ABBOTT MEDICAL | 2012-12-19 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S041) | Boston Scientific Corp | 2012-12-19 |
| SPRINT QUATTRO LEADS (P920015/S099) | Medtronic, Inc. | 2012-12-19 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S037) | Medtronic, Inc. | 2012-12-19 |
| MERLIN HOME 6.1M (P910023/S307) | ABBOTT MEDICAL | 2012-12-19 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S006) | Medtronic | 2012-12-19 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S038) | Boston Scientific Corp | 2012-12-18 |
| PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM (P970029/S022) | Cryolife, Inc. | 2012-12-18 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S001) | Bolton Medical, Inc. | 2012-12-18 |
| HEARTWARE VENTRICULAR ASSISTE SYSTEM (P100047/S009) | Medtronic | 2012-12-18 |
| WALLSTENT (ILIAC) ENDOPROSTHESIS (P940019/S033) | Boston Scientific Scimed, Inc. | 2012-12-18 |
| RELIANCE IS-1/IS-4 ACTIVE AND PASSIVE FIXATION DEFIBRILATION LEADS (P910073/S114) | Boston Scientific | 2012-12-18 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S027) | Boston Scientific Corporation | 2012-12-18 |
| CURRENT FAMILY OF ICDS (P910023/S310) | ABBOTT MEDICAL | 2012-12-17 |
| CHILLI II COOL ABLATION CATHETER (P980003/S037) | Boston Scientific Corp | 2012-12-17 |
| PROMOTE FAMILY OF CRT-DS (P030054/S239) | ABBOTT MEDICAL | 2012-12-17 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S064) | Boston Scientific Corp | 2012-12-13 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S077) | W. L. Gore & Associates, Inc. | 2012-12-13 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S104) | Boston Scientific Scimed, Inc. | 2012-12-13 |
| EXCOSEAL VASCULAR CLOSURE DEVICE (P100013/S007) | Cordis US Corporation | 2012-12-13 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S037) | Boston Scientific Corp | 2012-12-13 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S039) | Boston Scientific Corp | 2012-12-13 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S099) | Boston Scientific Scimed, Inc. | 2012-12-13 |
| CORONARY FLEXTOME CUTTING BALLON (P950020/S058) | Boston Scientific Corp | 2012-12-13 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S044) | Cook, Inc. | 2012-12-12 |
| RELIANCE DF4 LEADS (P910073/S113) | Boston Scientific | 2012-12-12 |
| ADVISA DR IPG (P980035/S300) | Medtronic, Inc. | 2012-12-12 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD (P980016/S388) | Medtronic Cardiac Rhythm Disease Management | 2012-12-12 |
| GEM II VR ICD,MARQUIS VR ICD,GEM III VR ICD,MAXIMO VR ICD,GEM DR ICD,GEM II DR ICD,MARQUIS DR ICD,GEM III DR ICD (P980016/S390) | Medtronic Cardiac Rhythm Disease Management | 2012-12-12 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S183) | Medtronic, Inc. | 2012-12-12 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S182) | Medtronic, Inc. | 2012-12-12 |
| ADVISA DR IPG (P980035/S298) | Medtronic, Inc. | 2012-12-12 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S047) | Cook, Inc. | 2012-12-12 |
| CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D AND PROTECTA XT CRT-D (P010031/S340) | Medtronic Cardiac Rhythm Disease Management | 2012-12-12 |
| JEWEL ICD, JEWEL PLUS ICD, MICRO JEWEL ICD, MICRO JEWEL II ICD, GEM ICD (P900061/S117) | Medtronic Cardiac Rhythm Disease Management | 2012-12-12 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S038) | Boston Scientific Corp | 2012-12-11 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S040) | Boston Scientific Corp | 2012-12-11 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S105) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| REPLY/ESPRIT PACEMAKERS (P950029/S072) | MicroPort CRM USA, Inc. | 2012-12-11 |
| FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S059) | Boston Scientific Corp | 2012-12-11 |
| WALLSTENT ILIAC ENDOPROSTHESIS (P940019/S034) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| VERIFLEX MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM (P040016/S103) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S296) | Medtronic, Inc. | 2012-12-11 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S012) | Boston Scientific Corp | 2012-12-11 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS,CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S049) | Edwards Lifesciences, LLC | 2012-12-11 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S099) | Boston Scientific Corp | 2012-12-11 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 CR (P010031/S341) | Medtronic Cardiac Rhythm Disease Management | 2012-12-11 |
| TAXUS LIBERTE MONORAIL AND AND OVER-THE-WIRE CORONARY STENT SYSTEM (P060008/S100) | Boston Scientific Corp | 2012-12-11 |
| COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, ENERGEN (P010012/S316) | Boston Scientific Corp | 2012-12-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S038) | Edwards Lifesciences, LLC | 2012-12-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM,RETROFLEX BALLOON CATHETER (P110021/S002) | Edwards Lifesciences, LLC | 2012-12-11 |
| MEDTRONIC CARELINK 2290 (P890003/S263) | Medtronic, Inc. | 2012-12-11 |
| EXPRESS2 MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S098) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S054) | Edwards Lifesciences, LLC | 2012-12-11 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S102) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM RETROFLEX BALLOON CATHETER EDWARDS (P100041/S017) | Edwards Lifesciences, LLC | 2012-12-11 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S099) | Boston Scientific Corp | 2012-12-11 |
| VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S005) | Boston Scientific Corp | 2012-12-11 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S063) | Boston Scientific Corp | 2012-12-11 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S038) | Boston Scientific Corp | 2012-12-11 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S039) | Boston Scientific Corp | 2012-12-11 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S101) | Boston Scientific Corp | 2012-12-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMAFIX (P860057/S097) | Edwards Lifesciences, LLC | 2012-12-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S036) | Edwards Lifesciences, LLC | 2012-12-11 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S065) | Boston Scientific Corp | 2012-12-11 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S019) | Boston Scientific Corporation | 2012-12-11 |
| TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD (P960040/S282) | Boston Scientific | 2012-12-11 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S028) | Boston Scientific Corporation | 2012-12-11 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S118) | Boston Scientific Corp | 2012-12-11 |
| OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S001) | Endologix, LLC | 2012-12-11 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S057) | Boston Scientific Corp | 2012-12-11 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S100) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S097) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| MAXIMO II DF4 CRT-D, MAXIMO II DF4 ICD, MAXIMO II ICD, PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT (P980016/S391) | Medtronic Cardiac Rhythm Disease Management | 2012-12-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S016) | Edwards Lifesciences, LLC | 2012-12-10 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S037) | Edwards Lifesciences, LLC | 2012-12-10 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S048) | Edwards Lifesciences, LLC | 2012-12-10 |
| CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES (P870056/S053) | Edwards Lifesciences, LLC | 2012-12-10 |
| VARIOUS FAMILIES OF PERIMOUNT, RSR, THEON, RSR PERICARDIAL AORTIC BIOPROSTHESES & VARIOUS FAMILIES OF MAGNA, THEON, PLUS (P860057/S096) | Edwards Lifesciences, LLC | 2012-12-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S001) | Edwards Lifesciences, LLC | 2012-12-10 |