| KAPPA 400 (P970012/S091) | Medtronic, Inc. | 2012-04-25 |
| GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST (P980016/S347) | Medtronic Cardiac Rhythm Disease Management | 2012-04-25 |
| PASYS, PASUS ST, SPECTRAX, SYMBIOS AND SYMBIOS FAMILIES (P820003/S116) | Medtronic Cardiac Rhythm Disease Management | 2012-04-25 |
| GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD (P900061/S114) | Medtronic Cardiac Rhythm Disease Management | 2012-04-25 |
| DIVA FAMILY, SELECTION AFM C-SERIES AND T-SERIES DEVICES (P980050/S073) | Medtronic, Inc. | 2012-04-25 |
| ACTIVITRAX, LEGEND, LEGEND II, MINIX, PEMIER, PREVAIL, VITATRON (P850051/S079) | Medtronic, Inc. | 2012-04-25 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S013) | Boston Scientific Corp | 2012-04-24 |
| INTERTACH (P860007/S024) | Boston Scientific | 2012-04-23 |
| VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P890061/S020) | Boston Scientific | 2012-04-23 |
| SELUTE LEAD SYSTEM FAMILY (P950001/S023) | Boston Scientific | 2012-04-23 |
| CONTAK RENEWAL TR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM FAMILY (P030005/S082) | Guidant Corp. | 2012-04-23 |
| ENDURANT STENT GRAFT SYSTEMS (P100021/S014) | Medtronic Vascular | 2012-04-23 |
| ACUITY STEERABLE LEAD SYSTEM FAMILY (P050046/S014) | Guidant Corp. | 2012-04-23 |
| CYBERLITH (P800019/S013) | Boston Scientific | 2012-04-23 |
| VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P830060/S070) | Boston Scientific | 2012-04-23 |
| VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES (P940031/S072) | Boston Scientific | 2012-04-23 |
| CAPSUREFIX MRI SURESCAN 5086MRI (P090013/S059) | Medtronic, Inc. | 2012-04-23 |
| INCEPTA, ENERGEN AND PUNTUA IDCS (P960040/S256) | Boston Scientific | 2012-04-23 |
| DELTA/VISTA FAMILIES (P840068/S050) | Boston Scientific | 2012-04-23 |
| MAXIMO II, MAXIMO II ICD, PROTECTA, PROTECTA ICD, PROTECTA XT, PROTECTA XT ICD, SECURA, SECURA ICD,VIRTUOSO II DR/VR ICD (P980016/S346) | Medtronic Cardiac Rhythm Disease Management | 2012-04-23 |
| THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S051) | Boston Scientific | 2012-04-23 |
| RELAY (P910020/S027) | Boston Scientific | 2012-04-23 |
| CONSULTA II CRT-D, CONSULTA, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA, PROTECTA XT (P010031/S298) | Medtronic Cardiac Rhythm Disease Management | 2012-04-23 |
| ENDOTAK LEAD SYSTEM FAMILY (P910073/S101) | Boston Scientific | 2012-04-23 |
| CYBERTACH PULSE GENERATOR SYSTEM (P820022/S005) | Boston Scientific | 2012-04-23 |
| INCEPTA, ENERGEN AND PUNTUA CRT-DS (P010012/S286) | Boston Scientific Corp | 2012-04-23 |
| VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERSTER DEFIBRILLATOR (AICD) FAMILIES (P910077/S120) | Boston Scientific | 2012-04-23 |
| VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P930035/S021) | Boston Scientific | 2012-04-23 |
| COSMOS (P830026/S080) | Boston Scientific | 2012-04-23 |
| SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEM FAMILIES (P960006/S033) | Boston Scientific | 2012-04-23 |
| RES-Q / RES-Q MICRON PULSE GENERATOR SYSTEM FAMILIES (P940008/S029) | Boston Scientific | 2012-04-23 |
| SPECTRANETICS LASER SHEATH DEVICE (P960042/S031) | Spectranetics (Philips) | 2012-04-20 |
| ION PACLITAXEL-ELUTING STENT SYSTEM (P100023/S039) | Boston Scientific Corp | 2012-04-19 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH WIRECLIP TORQUER (P900056/S113) | Boston Scientific Corp | 2012-04-19 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S051) | Boston Scientific Corp | 2012-04-19 |
| PARADYM CRT (P060027/S039) | MicroPort CRM USA, Inc. | 2012-04-19 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S011) | Boston Scientific Corp | 2012-04-19 |
| TAXUS LIBERTE PACLITAXEL-ELYTING CORONARY STENT SYSTEM (P060008/S086) | Boston Scientific Corp | 2012-04-19 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S095) | Boston Scientific Corp | 2012-04-19 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S033) | Boston Scientific | 2012-04-19 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S035) | Boston Scientific Corp | 2012-04-19 |
| REPLY SR/DR, ESPRIT SR/DR (P950029/S067) | MicroPort CRM USA, Inc. | 2012-04-19 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S025) | Boston Scientific Corp | 2012-04-19 |
| PARADYM VR/DR (P980049/S072) | MicroPort CRM USA, Inc. | 2012-04-19 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S082) | Boston Scientific Scimed, Inc. | 2012-04-19 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S085) | Boston Scientific Scimed, Inc. | 2012-04-19 |
| GEM III AT (P980050/S070) | Medtronic, Inc. | 2012-04-16 |
| SECURA/MAXIMO II/PROTECTA /PROTECTA XT/ENTRUST/ENTRUST DR (P980016/S339) | Medtronic Cardiac Rhythm Disease Management | 2012-04-16 |
| CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S292) | Medtronic Cardiac Rhythm Disease Management | 2012-04-16 |
| IMPLANTABLE CARDIAC PACEMAKER PULSE GENERATOR (P880006/S076) | St. Jude Medical, Inc. | 2012-04-13 |
| FRONTIER (P030035/S090) | ABBOTT MEDICAL | 2012-04-13 |
| TIERED THERAPY IMPLANTABLE DEFIBRILLATOR (P880086/S212) | ABBOTT MEDICAL | 2012-04-13 |
| CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (P960013/S069) | ABBOTT MEDICAL | 2012-04-13 |
| PASSIVE PLUS AND IOSFLEX LEAD FAMILIES (P960030/S035) | ABBOTT MEDICAL | 2012-04-13 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S030) | Edwards Lifesciences, LLC | 2012-04-13 |
| BIOCOR & BIOCOR SUPRA VALVES, EPIC & EPIC SUPRA VALVES (P040021/S021) | ABBOTT MEDICAL | 2012-04-13 |
| TRANSTELEPHONIC FOLLOW-UP/MONITORING SYSTEM (P910023/S281) | ABBOTT MEDICAL | 2012-04-13 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S042) | Medtronic, Inc. | 2012-04-13 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM (P110010/S012) | Boston Scientific Corp | 2012-04-13 |
| CARPENTIER-EDWARDS® SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S032) | Edwards Lifesciences, LLC | 2012-04-13 |
| TENDRIL AND OPTISENSE LEAD FAMILIES (P960013/S071) | ABBOTT MEDICAL | 2012-04-13 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S009) | Boston Scientific Corp | 2012-04-13 |
| VARIOUS FAMILIES OF CURRENT, ATLAS, EPIC, CONVERT, CURRENT, & FORTIFY ICD'S (P910023/S291) | ABBOTT MEDICAL | 2012-04-13 |
| CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (P960030/S034) | ABBOTT MEDICAL | 2012-04-13 |
| CARPENTIER-EDWARDS® DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHES (P870077/S043) | Edwards Lifesciences, LLC | 2012-04-13 |
| IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, & ACCENT FAMILIES OF IPG'S (P880086/S216) | ABBOTT MEDICAL | 2012-04-13 |
| IMPLANTABLE PACEMAKER PULSE GENERATOR (P970013/S045) | ABBOTT MEDICAL | 2012-04-13 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S042) | Cook, Inc. | 2012-04-13 |
| CARPENTIER-EDWARDS® PORCINE BIOPROSTHESIS (P870056/S048) | Edwards Lifesciences, LLC | 2012-04-13 |
| EPIC SELF-EXPANDING NITINOL STENT SYSTEM (P110035) | Boston Scientific Corp | 2012-04-13 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S037) | Boston Scientific Corp | 2012-04-13 |
| TRIFECTA VALVE (P100029/S011) | ABBOTT MEDICAL | 2012-04-13 |
| TRANSVENOUS DEFIBRILLATION LEAD (P950022/S080) | ABBOTT MEDICAL | 2012-04-13 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S092) | Abbott Vascular, Inc. | 2012-04-13 |
| FRONTIER, FRONTIER II, ANTHEM FAMILIES OF CRTP'S (P030035/S094) | ABBOTT MEDICAL | 2012-04-13 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S035) | Medtronic, Inc. | 2012-04-13 |
| VARIOUS FAMILIES OF EPIC, ATLAS, PROMOTE, UNIFY CRT-D'S (P030054/S218) | ABBOTT MEDICAL | 2012-04-13 |
| DEFIBRILLATOR/AUTOMATIC IMPLANTABLE CARDIOVERTER (P030054/S208) | ABBOTT MEDICAL | 2012-04-13 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S087) | Edwards Lifesciences, LLC | 2012-04-13 |
| FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES (P020045/S042) | Medtronic Cryocath, LP | 2012-04-12 |
| PRESILLION PLUS COCR CORONARY STENT RX SYSTEM (P110004) | Medinol, Ltd. | 2012-04-12 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S015) | Medtronic Cryocath, LP | 2012-04-12 |
| INCEPTA, ENERGEN AND PUNTUA CRT-DS (P010012/S285) | Boston Scientific Corp | 2012-04-11 |
| INCEPTA, ENERGEN AND PUNTUA IDCS (P960040/S255) | Boston Scientific | 2012-04-11 |
| PARADYM CRT (P060027/S032) | MicroPort CRM USA, Inc. | 2012-04-10 |
| PERCLOSE A T 6F & PERCLOSE PROGLIDE (PROGLIDE) (P960043/S077) | Abbott Vascular, Inc. | 2012-04-10 |
| PARADYM VR/DR (P980049/S065) | MicroPort CRM USA, Inc. | 2012-04-10 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S016) | Abbott Vascular | 2012-04-09 |
| CAPSURE EPI (P950024/S037) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE/SP/SP/Z NOVUS/VITATRON IMPULSE II/EXCELLENCE S+/IMPLUSE (P850089/S084) | Medtronic Cardiac Rhythm Disease Management | 2012-04-06 |
| CADENCE ICD SYSTEM (P910023/S287) | ABBOTT MEDICAL | 2012-04-06 |
| CAPSURE FIX NOVUS (P090013/S042) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE VDD-2/CAPSURE BRILLIANT S+ (P890003/S237) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE FIX NOVUS/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+ (P930039/S063) | Medtronic, Inc. | 2012-04-06 |
| ATTAIN ABILITY (P080006/S035) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE FIX (P980016/S325) | Medtronic Cardiac Rhythm Disease Management | 2012-04-06 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S002) | Edwards Lifesciences, LLC | 2012-04-06 |
| SPRINT QUATTRO SECURE /S/SPRINT (P920015/S083) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE/SP NOVUS/VITATRON CRYSTALLINE/EXCELLENCE +/PS+ (P830061/S072) | Medtronic Cardiac Rhythm Disease Management | 2012-04-06 |
| ATTAIN OTW (P010015/S142) | Medtronic, Inc. | 2012-04-06 |