| SELECTSECURE LEAD, 3830 (P030036/S047) | Medtronic Cardiac Rhythm Disease Management | 2012-10-03 |
| ADAPTA/RELIA/SENSIA/VERSA (P980035/S252) | Medtronic, Inc. | 2012-10-03 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEADS (P930039/S073) | Medtronic, Inc. | 2012-10-03 |
| THINLINE II AND FINELINE II STEROX LEADS AND FINELINE II EZ STEROX LEADS (P960004/S055) | Boston Scientific | 2012-10-03 |
| UNIDIRECTIONAL THERMOCOOL SF NAV CATHETER (P030031/S045) | Biosense Webster, Inc. | 2012-10-02 |
| CONSULTA CRT-P, C4TR01, SYNCRA CRT-P C2TR01 (P010015/S177) | Medtronic, Inc. | 2012-10-01 |
| ADVISA DR-IPG A4DR01 (P980035/S291) | Medtronic, Inc. | 2012-10-01 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S043) | Cook, Inc. | 2012-10-01 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042) | Boston Scientific Corporation | 2012-09-28 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S030) | Bard Peripheral Vascular, Inc. | 2012-09-27 |
| E-LUMINEXX VASCULAR STENT (P080007/S011) | Bard Peripheral Vascular, Inc. | 2012-09-27 |
| EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S088) | Boston Scientific Scimed, Inc. | 2012-09-27 |
| IOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S053) | Boston Scientific Corp | 2012-09-27 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S030) | Boston Scientific Corp | 2012-09-27 |
| GORE HELIX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2090, HX2095 (P050006/S031) | W. L. Gore & Associates, Inc. | 2012-09-27 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S028) | Boston Scientific Corp | 2012-09-27 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S091) | Boston Scientific Scimed, Inc. | 2012-09-27 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S024) | Bard Peripheral Vascular | 2012-09-27 |
| KAPPA,SIGMA,ADAPTA,SENSA,ADVISA,REVO MRI,ENRHYTHM MRI,RELIA,VERSA,AND ENPULSE FAMILIES OF IPGS (P980035/S290) | Medtronic, Inc. | 2012-09-25 |
| CONCERTO,MAXIMO,CONSULTA,INSYNC SENTRY,MARQUIS,VIRTUOSO,SECURA,AND PROTECTA FAMILIES OF ICDS (P010031/S334) | Medtronic Cardiac Rhythm Disease Management | 2012-09-25 |
| REVO MRI,AND ENRHYTHM MRI FAMILIES OF IPGS (P090013/S072) | Medtronic, Inc. | 2012-09-25 |
| LATTITUDE PATIENT MANAGEMENT SYSTEM (P910077/S123) | Boston Scientific | 2012-09-25 |
| ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM (P100021/S020) | Medtronic Vascular | 2012-09-25 |
| SYNERGYST,ELITE,MINUET,PRELUDE,THERA,PRODIGY,PREVA, J EWEL,AND REVEAL FAMILIES OF IPGS (P890003/S258) | Medtronic, Inc. | 2012-09-25 |
| INSYNC,CONSULTA,AND SYNCRA FAMILIES OF IPGS (P010015/S175) | Medtronic, Inc. | 2012-09-25 |
| VIRTUOSO,ENTRUST,MAXIMO,INTRINSIC,MARQUIS,CONCERTO,PROTECTA,SECURA,CONSULTA,GEM,AND ONYX FAMILIES OF ICDS (P980016/S381) | Medtronic Cardiac Rhythm Disease Management | 2012-09-25 |
| LINOX SMART (P980023/S047) | Biotronik, Inc. | 2012-09-24 |
| TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S269) | Boston Scientific | 2012-09-24 |
| ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY (P030054/S231) | ABBOTT MEDICAL | 2012-09-24 |
| IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES (P880086/S225) | ABBOTT MEDICAL | 2012-09-24 |
| COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S299) | Boston Scientific Corp | 2012-09-24 |
| ATLAS/ATLAS,ATLAS II/ATLAS II,CURRENT,CURRENT ACCEL,CURRENT,EPIC/EPIC,EPIC II/EPIC II,FORTIFY,FORTIFY ASSURA,ELLIPSE (P910023/S303) | ABBOTT MEDICAL | 2012-09-24 |
| REOCOR S/D EXTERNAL PACEMAKER (P950037/S111) | Biotronik, Inc. | 2012-09-24 |
| FRONTIER, FRONTIER II, ANTHEM FAMILY OF DEVICES (P030035/S103) | ABBOTT MEDICAL | 2012-09-24 |
| OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM (P110043/S002) | Abbott Vascular-Cardiac Therapies | 2012-09-24 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P110010/S029) | Boston Scientific Corp | 2012-09-21 |
| BLAZER PRIME XP TEMPERATURE ABLATION CATHETER (P020025/S035) | Boston Scientific | 2012-09-21 |
| CRYOBLATION CONSOLE (P100010/S018) | Medtronic Cryocath, LP | 2012-09-21 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S033) | Boston Scientific Corp | 2012-09-21 |
| EXPRESS CORONARY STENT SYSTEM (MONORAIL) (P020009/S091) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| RX ACCULINK CARTOID STENT SYSTEM (P040012/S049) | Abbott Vascular | 2012-09-21 |
| TALENT ABDOMINAL STENT GRAFT (P070027/S035) | Medtronic Vascular | 2012-09-21 |
| EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S003) | Boston Scientific Corp | 2012-09-21 |
| TAXUS LIBERTE PACILITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P060008/S095) | Boston Scientific Corp | 2012-09-21 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S024) | Boston Scientific Corporation | 2012-09-21 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P100023/S054) | Boston Scientific Corp | 2012-09-21 |
| VERIFLEX BARE MAETAL CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P040016/S097) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S036) | Medtronic Vascular | 2012-09-21 |
| WALLSTENT TRANSJUGULAR PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS (P930031/S035) | Boston Scientific Corp | 2012-09-21 |
| FLEXTOME CUTTING BALLOON DILATATION DEVICE (MONORAIL & OVER-THE-WIRE) (P950020/S054) | Boston Scientific Corp | 2012-09-21 |
| CRYOCONSOLE, MODEL 106A3 (P020045/S045) | Medtronic Cryocath, LP | 2012-09-21 |
| BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER (P920047/S053) | Boston Scientific Corp | 2012-09-21 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (MONORAIL) (P040016/S096) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S096) | Boston Scientific Corp | 2012-09-21 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038) | Bolton Medical, Inc. | 2012-09-21 |
| WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S030) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| EXPRESS2 CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P020009/S092) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| VALIANT THORACIC STENT GRAFT (P100040/S009) | Medtronic Vascular | 2012-09-21 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S034) | Bard Peripheral Vascular, Inc. | 2012-09-21 |
| MAXIMO II DF-4 CRT-D, MAXIMO II DF-4 ICD, MAXIMO II ICD, PROTECTA DF4-ICD, PROTECTA ICD, PROTECTA XT DF-4 ICD, PROTECTA (P980016/S379) | Medtronic Cardiac Rhythm Disease Management | 2012-09-20 |
| PROTECTA ICD, PROTECTA XT ICD (P980016/S380) | Medtronic Cardiac Rhythm Disease Management | 2012-09-20 |
| PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S333) | Medtronic Cardiac Rhythm Disease Management | 2012-09-20 |
| CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 (P010031/S332) | Medtronic Cardiac Rhythm Disease Management | 2012-09-20 |
| THERMOCOOL SF CATHETERS (BI-DIRECTIONAL), THERMOCOOL SF CATHETERS (UNI-DIRECTIONAL) (P030031/S047) | Biosense Webster, Inc. | 2012-09-20 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S003) | Cordis US Corporation | 2012-09-19 |
| ADAPTA ADSR01, ADSR03, ADSR06, RELIA RESO1, RESR01, SENSIA SES01, SESR01 (P980035/S288) | Medtronic, Inc. | 2012-09-19 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S094) | Abbott Vascular, Inc. | 2012-09-19 |
| CAPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P870077/S046) | Edwards Lifesciences, LLC | 2012-09-19 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S331) | Medtronic Cardiac Rhythm Disease Management | 2012-09-19 |
| CAPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S091) | Edwards Lifesciences, LLC | 2012-09-19 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S174) | Medtronic, Inc. | 2012-09-19 |
| ADVISA DR IPG (P980035/S289) | Medtronic, Inc. | 2012-09-19 |
| ATTAIN ABILITY LEADS, 4196, 4296, AND 4396 (P080006/S043) | Medtronic, Inc. | 2012-09-19 |
| CARPENTIER-EDWARDS S.A.V. NIOPROSTHESIS (P010041/S035) | Edwards Lifesciences, LLC | 2012-09-19 |
| PRODIGY, 8158 (P890003/S257) | Medtronic, Inc. | 2012-09-19 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S033) | Edwards Lifesciences, LLC | 2012-09-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S014) | Edwards Lifesciences, LLC | 2012-09-19 |
| XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S020) | Abbott Vascular | 2012-09-19 |
| CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS (P870056/S051) | Edwards Lifesciences, LLC | 2012-09-19 |
| ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP) (P000037/S029) | On-X Life Technologies, Inc. | 2012-09-19 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S378) | Medtronic Cardiac Rhythm Disease Management | 2012-09-19 |
| PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 (P010031/S305) | Medtronic Cardiac Rhythm Disease Management | 2012-09-17 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM (P110010/S024) | Boston Scientific Corp | 2012-09-17 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S049) | Boston Scientific Corp | 2012-09-17 |
| ACCENT FAMILY OF PACEMAKERS (P880086/S222) | ABBOTT MEDICAL | 2012-09-14 |
| XIENCE PRIME AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S009) | Abbott Vascular | 2012-09-14 |
| ANTHEM FAMILY OF PACEMAKERS (P030035/S100) | ABBOTT MEDICAL | 2012-09-14 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S087) | Abbott Vascular, Inc. | 2012-09-14 |
| THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S001) | ABBOTT MEDICAL | 2012-09-13 |
| TENDRIL FAMILY OF LEADS (P960013/S068) | ABBOTT MEDICAL | 2012-09-13 |
| DURATA LEADS (P950022/S079) | ABBOTT MEDICAL | 2012-09-13 |
| CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM (P970029/S021) | Cryolife, Inc. | 2012-09-13 |
| DDMA SOFTWARE (P890003/S251) | Medtronic, Inc. | 2012-09-12 |
| ACCENT FAMILY OF DEVICES (P880086/S224) | ABBOTT MEDICAL | 2012-09-12 |
| ANTHEM FAMILY OF DEVICES (P030035/S102) | ABBOTT MEDICAL | 2012-09-12 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S033) | Bard Peripheral Vascular, Inc. | 2012-09-12 |
| MAXIMO II DF4 ICD, SECURA DF4 ICD (P980016/S362) | Medtronic Cardiac Rhythm Disease Management | 2012-09-12 |
| PUNTUA, INCEPTA AND ENERGEN CRT-D FAMILIES (P010012/S298) | Boston Scientific Corp | 2012-09-11 |
| PUNTUA, INCEPTA AND ENERGEN ICD'S FAMILIES (P960040/S268) | Boston Scientific | 2012-09-11 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ENRHYTHM IPG, RELIA IPG (P980035/S287) | Medtronic, Inc. | 2012-09-10 |