| CONSULTA AND SYNCRA CRT-PS (P010015/S164) | Medtronic, Inc. | 2012-07-25 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S014) | Corcym Canada Corp | 2012-07-25 |
| INCEPTA, COGNIS, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S289) | Boston Scientific Corp | 2012-07-25 |
| EXPRESS /EXPRESS MONORAIL CORONARY STENT SYSTEM (P020009/S089) | Boston Scientific Scimed, Inc. | 2012-07-25 |
| CONCERTO II CRT-D & VARIOUS FAMILIES OF MAXIMO II & PROTECTA CRT-DS' VARIOUS FAMILIES OF CONSULTA ICDS (P010031/S316) | Medtronic Cardiac Rhythm Disease Management | 2012-07-25 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S034) | Zoll Manufacturing Corporation | 2012-07-25 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS (P110013/S004) | Medtronic Vascular | 2012-07-25 |
| VIRTUOSO II DR/VR ICD & VARIOUS FAMILIES OF MAXIMO II, PROTECTA & SECURA ICDS (P980016/S364) | Medtronic Cardiac Rhythm Disease Management | 2012-07-25 |
| XACT CAROTID STENT SYSTEM (P040038/S024) | Abbott Vascular, Inc. | 2012-07-24 |
| MAXIMO II, PROTECTA,PROTECTA XT, SECURA AND VIRTUOSO II (P980016/S314) | Medtronic Cardiac Rhythm Disease Management | 2012-07-23 |
| CELSIUS THERMOCOOL CATHETER (P030031/S043) | Biosense Webster, Inc. | 2012-07-23 |
| CONCERTO II. CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT (P010031/S268) | Medtronic Cardiac Rhythm Disease Management | 2012-07-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S019) | Boston Scientific Corp | 2012-07-20 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S004) | Cordis US Corporation | 2012-07-20 |
| TRANSVENE SVC LEAD (P920015/S090) | Medtronic, Inc. | 2012-07-18 |
| TRANSVENE LEADS (P980050/S072) | Medtronic, Inc. | 2012-07-18 |
| SELECTSECURE LEAD, 3830 (P030036/S044) | Medtronic Cardiac Rhythm Disease Management | 2012-07-18 |
| EPICARDIAL PATCH LEADS (P900061/S113) | Medtronic Cardiac Rhythm Disease Management | 2012-07-18 |
| THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S052) | Boston Scientific | 2012-07-18 |
| ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM (P860008/S022) | Cardio Command | 2012-07-18 |
| ZENITH RENU AAA ANCILLARY GRAFT (P020018/S039) | Cook, Inc. | 2012-07-17 |
| ENDOTAK LEAD SYSTEM (P910073/S103) | Boston Scientific | 2012-07-13 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S032) | Zoll Manufacturing Corporation | 2012-07-13 |
| STINGER, STINGER S, STINGER M, STINGER SM, SCORPION 2, SCORPION 2M ABLATION CATHETERS (P000020/S015) | Boston Scientific Corp | 2012-07-12 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S022) | Boston Scientific Corporation | 2012-07-12 |
| WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S033) | Boston Scientific Corp | 2012-07-12 |
| FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/RETRACTABLE PACING LEADS (P960006/S034) | Boston Scientific | 2012-07-12 |
| WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S028) | Boston Scientific Scimed, Inc. | 2012-07-12 |
| ENDOTAK RELIANCE EZ IS-1 ACTIVE FIZATION LEAD MODELS (P910073/S104) | Boston Scientific | 2012-07-12 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S021) | Boston Scientific Corporation | 2012-07-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S012) | Edwards Lifesciences, LLC | 2012-07-11 |
| WALLSTENT (CAROTID) ENDOPROSTHESIS (P050019/S009) | Boston Scientific Corp | 2012-07-11 |
| AUTOMATED ACCELEROMETER TEST SYSTEM UPDATE (P980035/S274) | Medtronic, Inc. | 2012-07-11 |
| XACT CAROTID STENT SYSTEM (P040038/S027) | Abbott Vascular, Inc. | 2012-07-11 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S019) | Medtronic Vascular | 2012-07-11 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S030) | Abbott Vascular Devices | 2012-07-11 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S050) | Edwards Lifesciences, LLC | 2012-07-11 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S045) | Boston Scientific Corp | 2012-07-11 |
| ON-X PROSTHETIC HEART VALVE (P000037/S027) | On-X Life Technologies, Inc. | 2012-07-11 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S048) | Abbott Vascular | 2012-07-11 |
| FLEXTOME CUTTING BALLOON (MONORAIL) (P950020/S051) | Boston Scientific Corp | 2012-07-11 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S096) | Abbott Vascular, Inc. | 2012-07-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSHESIS (P860057/S090) | Edwards Lifesciences, LLC | 2012-07-11 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S032) | Boston Scientific Corp | 2012-07-11 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (MONORAIL) (P110010/S017) | Boston Scientific Corp | 2012-07-11 |
| VERIFLEX CORONARY STENT SYSTEM (MONORAIL) (P040016/S089) | Boston Scientific Scimed, Inc. | 2012-07-11 |
| ATTAIN ABILITY (P080006/S041) | Medtronic, Inc. | 2012-07-11 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S007) | Abbott Vascular | 2012-07-11 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S024) | Abbott Vascular | 2012-07-11 |
| XACT CAROTID STENT SYSTEM (P040038/S026) | Abbott Vascular, Inc. | 2012-07-11 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S045) | Edwards Lifesciences, LLC | 2012-07-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S032) | Edwards Lifesciences, LLC | 2012-07-11 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S002) | Boston Scientific Corp | 2012-07-11 |
| HERCULINK ELITE PERIPHERAL STENT SYSTEM (P110001/S006) | Abbott Vascular | 2012-07-11 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM (P110010/S016) | Boston Scientific Corp | 2012-07-11 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P060008/S090) | Boston Scientific Corp | 2012-07-11 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S004) | Abbott Vascular, Inc. | 2012-07-11 |
| WALLSTENT (IIIAC) ENDOPROSTHESIS (P940019/S027) | Boston Scientific Scimed, Inc. | 2012-07-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S034) | Edwards Lifesciences, LLC | 2012-07-11 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P100023/S046) | Boston Scientific Corp | 2012-07-11 |
| ACCULINK, RX SELF-EXPANDING CARTOID STENT SYSTEM (P040012/S047) | Abbott Vascular | 2012-07-11 |
| SAFIRE BLU SP ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER (P060019/S021) | Irvine Biomedical, Inc. | 2012-07-10 |
| SAFIRE BLU DUO SP ABLATION CATHETERS (P110016/S002) | ABBOTT MEDICAL | 2012-07-10 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S116) | Boston Scientific Corp | 2012-07-06 |
| EPIC HF/ATLAS+HF/QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S224) | ABBOTT MEDICAL | 2012-07-06 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S098) | Boston Scientific Corp | 2012-07-06 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S097) | ABBOTT MEDICAL | 2012-07-06 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S015) | Boston Scientific Corp | 2012-07-06 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S080) | St. Jude Medical, Inc. | 2012-07-06 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S049) | ABBOTT MEDICAL | 2012-07-06 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S044) | Boston Scientific Corp | 2012-07-06 |
| CVX-300 ANTI-REFLECTIVE WINDOW (P910001/S057) | Spectranetics Corp. | 2012-07-06 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S029) | Boston Scientific Corp | 2012-07-06 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S086) | Boston Scientific Scimed, Inc. | 2012-07-06 |
| CADENCE/ ELLIPSE/ FORTIFY ASSURA FAMILY OF ICDS (P910023/S296) | ABBOTT MEDICAL | 2012-07-06 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S003) | Medtronic Vascular, Inc. | 2012-07-06 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S219) | ABBOTT MEDICAL | 2012-07-06 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S089) | Boston Scientific Corp | 2012-07-06 |
| CAPSURE, CAPSURE MODEL (P890003/S250) | Medtronic, Inc. | 2012-07-05 |
| SELECTSECURE LEAD, MODEL 3830 (P030036/S043) | Medtronic Cardiac Rhythm Disease Management | 2012-07-05 |
| SPRINT QUATTRO (P920015/S092) | Medtronic, Inc. | 2012-07-05 |
| CAPSURE Z NOVUS, CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, & IMPULSE II LEADS (P850089/S088) | Medtronic Cardiac Rhythm Disease Management | 2012-07-05 |
| CAPSUREFIX MRI LEAD (P090013/S064) | Medtronic, Inc. | 2012-07-05 |
| CAPSURE, VITATRON CRYSTALINE, & VITATRON EXCELLENCE PS+ (P830061/S076) | Medtronic Cardiac Rhythm Disease Management | 2012-07-05 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S273) | Medtronic, Inc. | 2012-07-05 |
| TRANSVENE LEAD, MODEL 6937A (P980050/S074) | Medtronic, Inc. | 2012-07-05 |
| THORATEC HEARTMATE II LVAS (P060040/S022) | ABBOTT MEDICAL | 2012-07-05 |
| CAPSUREFIX, CAPSUREFIX NOVUS, SUREFIX, & VITATRON CRYSTALLINE LEADS (P930039/S068) | Medtronic, Inc. | 2012-07-05 |
| SYNCARDIA COMPANION 2 DRIVER SYSTEM (P030011/S013) | Syncardia Systems, LLC | 2012-07-05 |
| SPECTRANETICS EXCIMER LASER (P910001/S056) | Spectranetics Corp. | 2012-07-03 |
| INCEPTA, ENERGEN, PUNTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S264) | Boston Scientific | 2012-07-03 |
| INCEPTA, ENERGEN, PUNCTUA (P010012/S294) | Boston Scientific Corp | 2012-07-03 |
| SPRINT QUATTRO SINGLE COIL DF4, ACTIVE FIXATION LEAD (P920015/S091) | Medtronic, Inc. | 2012-07-02 |
| TRIFECTA VALVE (P100029/S013) | ABBOTT MEDICAL | 2012-06-29 |
| ETHICON OMNEX SURGICAL SEALANT (P060029/S004) | ETHICON, Inc. | 2012-06-29 |
| CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S051) | Corcym S.r.l. | 2012-06-29 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S025) | Zoll Manufacturing Corporation | 2012-06-29 |
| PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 (P010031/S304) | Medtronic Cardiac Rhythm Disease Management | 2012-06-29 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S049) | Thoratec Laboratories Corp. | 2012-06-29 |
| DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S081) | ABBOTT MEDICAL | 2012-06-28 |