| REVO MRI IPG, RVDR01 (P090013/S071) | Medtronic, Inc. | 2012-09-10 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S088) | Abbott Vascular, Inc. | 2012-09-10 |
| SAFIRE ABLATION SYSTEM (P960016/S039) | St Jude Medical | 2012-09-10 |
| PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D (P010031/S314) | Medtronic Cardiac Rhythm Disease Management | 2012-09-10 |
| CARBOMEDICS PROSTHETIC HEART VLAVE (P900060/S049) | Corcym S.r.l. | 2012-09-10 |
| PRODIGY IPG 8158 (P890003/S256) | Medtronic, Inc. | 2012-09-10 |
| PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD (P980016/S361) | Medtronic Cardiac Rhythm Disease Management | 2012-09-10 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S011) | Abbott Vascular | 2012-09-10 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S070) | Abbott Vascular, Inc. | 2012-09-07 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S030) | W. L. Gore & Associates, Inc. | 2012-09-07 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S001) | Abbott Vascular-Cardiac Therapies | 2012-09-07 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S022) | Irvine Biomedical, Inc. | 2012-09-07 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S030) | Abbott Vascular | 2012-09-07 |
| THERAPY COOL PATH DUO ABLATION CATHETER (P110016/S004) | ABBOTT MEDICAL | 2012-09-07 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S099) | Abbott Vascular, Inc. | 2012-09-07 |
| FLEXTOME CUTTING BALLOON (P950020/S053) | Boston Scientific Corp | 2012-09-07 |
| ACCENT FAMILY OF DEVICES (P880086/S221) | ABBOTT MEDICAL | 2012-09-06 |
| WALLSTENT TRANSJUGULAR PORTOSYSTEMICSHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S034) | Boston Scientific Corp | 2012-09-06 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) (P100023/S052) | Boston Scientific Corp | 2012-09-06 |
| VERIFLEX CORONARY STENT SYSTEM (MONORAIL) (P040016/S095) | Boston Scientific Scimed, Inc. | 2012-09-06 |
| WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S029) | Boston Scientific Scimed, Inc. | 2012-09-06 |
| ANTHEM FAMILY OF DEVICES (P030035/S099) | ABBOTT MEDICAL | 2012-09-06 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S010) | Boston Scientific Corp | 2012-09-06 |
| SJM ELLIPSE AND FORTIFY ASSURA ICDS (P910023/S298) | ABBOTT MEDICAL | 2012-09-06 |
| FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S052) | Boston Scientific Corp | 2012-09-06 |
| SJM QUADRA ASSURA AND UNIFY ASSURA CRTDS (P030054/S227) | ABBOTT MEDICAL | 2012-09-06 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P060008/S094) | Boston Scientific Corp | 2012-09-06 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) (P110010/S027) | Boston Scientific Corp | 2012-09-06 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S023) | Boston Scientific Corporation | 2012-09-06 |
| EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM (P090003/S015) | Boston Scientific Corporation | 2012-09-06 |
| SPECTRANENETICS LASER SHEATHS SLS (P960042/S041) | Spectranetics (Philips) | 2012-09-05 |
| CONCERTO II, CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S330) | Medtronic Cardiac Rhythm Disease Management | 2012-09-05 |
| CONSULTA CRT-P, C4TR01 AND SYNCRA CRT-P, C2TR01 (P010015/S173) | Medtronic, Inc. | 2012-09-05 |
| REVO MRI IPG, RVDR01 (P090013/S070) | Medtronic, Inc. | 2012-09-05 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S061) | Spectranetics Corp. | 2012-09-05 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG (P980035/S286) | Medtronic, Inc. | 2012-09-05 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S172) | Medtronic, Inc. | 2012-09-05 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S377) | Medtronic Cardiac Rhythm Disease Management | 2012-09-05 |
| PROTECTA CRT-D, D334TRG, D334TRM, PROTECTA XT CRT-D, D314TRG, D314TRM (P010031/S327) | Medtronic Cardiac Rhythm Disease Management | 2012-09-04 |
| PROTECTA ICD AND PROTECTA XT ICD (P980016/S374) | Medtronic Cardiac Rhythm Disease Management | 2012-09-04 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S032) | Boston Scientific Corp | 2012-08-31 |
| MAXIMO II ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD (P980016/S375) | Medtronic Cardiac Rhythm Disease Management | 2012-08-31 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS (P040016/S094) | Boston Scientific Scimed, Inc. | 2012-08-31 |
| EXPRESS CORONARY STENT SYSTEMS (P020009/S090) | Boston Scientific Scimed, Inc. | 2012-08-31 |
| CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD AND MAXIMO II CRT-D (P010031/S328) | Medtronic Cardiac Rhythm Disease Management | 2012-08-31 |
| ENDEAOVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S071) | Medtronic, Inc. | 2012-08-31 |
| CURRENT, FORTIFY, ELLIPSE ASSURA FAMILY OF ICD DEVICES (P910023/S300) | ABBOTT MEDICAL | 2012-08-30 |
| ATTAIN STARFIX LEAD, 4195 (P060039/S035) | Medtronic, Inc. | 2012-08-30 |
| CAPSUREFIX MRI LEAD 6086MRI, REVO MRI IPG, RVDR01 (P090013/S069) | Medtronic, Inc. | 2012-08-30 |
| ATTAIN ABILITY LEADS 4196, 4296 AND 4396 (P080006/S042) | Medtronic, Inc. | 2012-08-30 |
| CAPSURE EPICARDIAL PACING LEAD, 4665, 4968 (P950024/S042) | Medtronic, Inc. | 2012-08-30 |
| CAPSURE LEADS, VITATRON CRYSTALINE LEADS, VITATRON EXCELLENCE PS+ LEADS (P830061/S077) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| VITATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG (P990001/S108) | Medtronic, Inc. | 2012-08-30 |
| Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO L (P920015/S094) | Medtronic, Inc. | 2012-08-30 |
| CAPSURE LEADS 5038, 5038L, 5038S,IMW14Q,IMW15Q, IMW16Q, IMW17Q, IMW18Q, PRODIGY IPG, 8158 (P890003/S255) | Medtronic, Inc. | 2012-08-30 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD SYNCRA CRT-P (P010015/S171) | Medtronic, Inc. | 2012-08-30 |
| CAPSURE SP NOVUS LEADS, CAPSURE SP Z LEADS, CAPSURE Z NOVUS LEAD, CAPSURE Z NOVUS LEADS, IMPULSE II LEADS (P850089/S089) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| END CAP 6701,EPICARDIAL PATCH LEAD 6721L, 6721M, 6721S,SIZING SLEEVE 6920,UPSIZING SLEEVE 6925 (P900061/S115) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ADVISA DR IPG, ENRHYTHM IPG, RELIA IPG, SIGMA DR IPG, SIGMA S I (P980035/S285) | Medtronic, Inc. | 2012-08-30 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S046) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II ICD, MAXIMO VR ICD, PROTECTA ICD, (P980016/S373) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| EPIC, ATLAS, PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S228) | ABBOTT MEDICAL | 2012-08-30 |
| CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO II CRT-D, PROTECT (P010031/S326) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| TRANSVENE LEAD, 6937 A (P980050/S075) | Medtronic, Inc. | 2012-08-30 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD, VITATRON CRYSTA (P930039/S071) | Medtronic, Inc. | 2012-08-30 |
| ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES (P040021/S022) | ABBOTT MEDICAL | 2012-08-30 |
| INVIVE CRT-P AND ZOOMVIEW PROGRAMMER (P030005/S086) | Guidant Corp. | 2012-08-29 |
| RELIATY / MODEL 3145 PACING SYSTEM (P950037/S109) | Biotronik, Inc. | 2012-08-28 |
| CONSULTA CRT-P AND SYNCRA CRT-P (P010015/S170) | Medtronic, Inc. | 2012-08-27 |
| ADVISA DR IPG, A4DR01 (P980035/S284) | Medtronic, Inc. | 2012-08-27 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S098) | Abbott Vascular, Inc. | 2012-08-27 |
| MAXIMO II ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S372) | Medtronic Cardiac Rhythm Disease Management | 2012-08-27 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S325) | Medtronic Cardiac Rhythm Disease Management | 2012-08-27 |
| ACUITY STEERABLE IMPLANTABLE LEADS (P050046/S015) | Guidant Corp. | 2012-08-27 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S028) | Abbott Vascular | 2012-08-27 |
| CRYOABLATION CONSOLE (P100010/S017) | Medtronic Cryocath, LP | 2012-08-24 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S050) | Abbott Vascular | 2012-08-24 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLQTINUM CHROMIUM STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P110010/S020) | Boston Scientific Corp | 2012-08-24 |
| RX ACCULINK CARTOID STENT SYSTEM (P040012/S044) | Abbott Vascular | 2012-08-24 |
| CRYOABLATION CONSOLE (P020045/S044) | Medtronic Cryocath, LP | 2012-08-24 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S027) | Abbott Vascular | 2012-08-24 |
| PARADYM CRT-D, PARADYM RF CRT-D (P060027/S045) | MicroPort CRM USA, Inc. | 2012-08-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE) (P110010/S021) | Boston Scientific Corp | 2012-08-23 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S043) | Medtronic, Inc. | 2012-08-23 |
| PARADYM VR AND DR, PARADYM RF VR AND DR (P980049/S077) | MicroPort CRM USA, Inc. | 2012-08-23 |
| REPLY SR AND DR, ESPRIT SR AND DR (P950029/S071) | MicroPort CRM USA, Inc. | 2012-08-23 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S371) | Medtronic Cardiac Rhythm Disease Management | 2012-08-22 |
| AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM (P040002/S038) | Endologix, LLC | 2012-08-22 |
| ION PACLITAXEL-ELUTING CORONARY SYSTEM (MONORAIL AND OVER THE WIRE) (P100023/S051) | Boston Scientific Corp | 2012-08-22 |
| FORTIFY VR DF-4 FAMILY OF ICDS (P910023/S299) | ABBOTT MEDICAL | 2012-08-22 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM (P040042/S024) | Irvine Biomedical,Inc.(Ibi) | 2012-08-22 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S324) | Medtronic Cardiac Rhythm Disease Management | 2012-08-22 |
| COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S297) | Boston Scientific Corp | 2012-08-22 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S169) | Medtronic, Inc. | 2012-08-22 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S283) | Medtronic, Inc. | 2012-08-22 |
| TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S267) | Boston Scientific | 2012-08-22 |
| THERAPY CARDIAC ABLATION SYSTEM (P040014/S019) | Irvine Biomedical, Inc. | 2012-08-22 |
| THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 (P060019/S020) | Irvine Biomedical, Inc. | 2012-08-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S008) | Edwards Lifesciences, LLC | 2012-08-20 |
| SYNCARDIA COMPANION 2 DRIVER SYSTEM (P030011/S016) | Syncardia Systems, LLC | 2012-08-20 |