| ACUITY STEERABLE FAMILY OF LV PACING LEADS (P050046/S017) | Guidant Corp. | 2012-11-09 |
| ENDOTAK FAMILY OF ICD LEADS (P910073/S109) | Boston Scientific | 2012-11-09 |
| VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, LIVIAN, & TELIGEN FAMILIES OF ICDS (P960040/S276) | Boston Scientific | 2012-11-09 |
| VENTAK PRIZM 2 FAMILIES, ICD (P890061/S021) | Boston Scientific | 2012-11-09 |
| CONTAK & RENEWAL TR FAMILY, CRT-P (P030005/S090) | Guidant Corp. | 2012-11-09 |
| EXPRESS LD ILLIAC PREMOUNTED STENT SYSTEM (P090003/S018) | Boston Scientific Corporation | 2012-11-09 |
| SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND FAMILIES OF PACING LEADS (P960006/S036) | Boston Scientific | 2012-11-09 |
| DELTA, VISTA FAMILIES, PACEMAKER (P840068/S051) | Boston Scientific | 2012-11-09 |
| VENTAK PRX/VENTAK MINI FAMILIES OF ICDS (P910077/S126) | Boston Scientific | 2012-11-09 |
| RES-Q FAMILY OF ICD/ICD LEADS, RES-Q MICRON FAMILY OF ICDS (P940008/S030) | Boston Scientific | 2012-11-09 |
| VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES OF PACEMAKERS (P940031/S073) | Boston Scientific | 2012-11-09 |
| VENTAK PRIZM 2 FAMILIES, ICD (P930035/S023) | Boston Scientific | 2012-11-09 |
| VENTAK , VENTAK PRIZM, ICD (P830060/S073) | Boston Scientific | 2012-11-09 |
| THINLINE/FINELINE FAMILIES OF PACING LEADS (P960004/S057) | Boston Scientific | 2012-11-09 |
| CONTAK RENEWAL 3 CRT-DS, CONTAK RENEWAL 3 HE CRT-DS, LIVIAN CRT-DS, PUNCTUA CRT-DS (P010012/S307) | Boston Scientific Corp | 2012-11-07 |
| CONTAK RENEWAL TR CRT-PS, CONTAK RENEWAL TR 2 CRT-PS, INVIVE CRT-PS (P030005/S089) | Guidant Corp. | 2012-11-07 |
| ARCTIC FRONT CARDIAC CYROABLATION CATHETER, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER (P100010/S020) | Medtronic Cryocath, LP | 2012-11-07 |
| MAXIMO II CRT-D, MAXIMO II ICD, MAXIMO II ICD, PROTECTA ICD AND PROTECTA XT ICD (P980016/S386) | Medtronic Cardiac Rhythm Disease Management | 2012-11-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S072) | W. L. Gore & Associates, Inc. | 2012-11-07 |
| GORE HELEX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2030, HX2035 (P050006/S032) | W. L. Gore & Associates, Inc. | 2012-11-07 |
| COGNIS, INCEPTA CRT-D, ENERGEN CRT-D, PUNCTUA CRT-D (P010012/S312) | Boston Scientific Corp | 2012-11-07 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S004) | Medtronic Vascular, Inc. | 2012-11-07 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S047) | W. L. Gore & Associates, Inc. | 2012-11-07 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S034) | Boston Scientific Corp | 2012-11-07 |
| SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS (P120002) | Cordis US Corporation | 2012-11-07 |
| ACUITY SPIRAL (P910073/S110) | Boston Scientific | 2012-11-07 |
| LATITUDE G2 COMMUNICATOR (P910077/S127) | Boston Scientific | 2012-11-07 |
| EXPRESS AND EXPRESS CORONARY STENT SYSTEMS (P020009/S093) | Boston Scientific Scimed, Inc. | 2012-11-07 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S051) | ABBOTT MEDICAL | 2012-11-07 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S (P030035/S101) | ABBOTT MEDICAL | 2012-11-07 |
| PRIZM HE, VITALITY, VITALITY 2, CONFIENT, PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICDS (P960040/S275) | Boston Scientific | 2012-11-07 |
| RELIANCE IS-1 (PASSIVE) DEFIBRILLATION LEAD (P010012/S309) | Boston Scientific Corp | 2012-11-07 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS (P040016/S098) | Boston Scientific Scimed, Inc. | 2012-11-07 |
| PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S279) | Boston Scientific | 2012-11-07 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS (P060001/S018) | Medtronic Vascular, Inc. | 2012-11-07 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S223) | ABBOTT MEDICAL | 2012-11-07 |
| CADENCE CURRENT FAMILY OF ICD'S (P910023/S302) | ABBOTT MEDICAL | 2012-11-07 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S082) | St. Jude Medical, Inc. | 2012-11-07 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S004) | Boston Scientific Corp | 2012-11-07 |
| EPIC HF/ ATLAS + HF PROMOTE FAMILY OF CRT-D'S (P030054/S230) | ABBOTT MEDICAL | 2012-11-07 |
| CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D. PROTECTA XT CRT-D (P010031/S338) | Medtronic Cardiac Rhythm Disease Management | 2012-11-07 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S011) | Edwards Lifesciences, LLC | 2012-11-06 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S093) | Boston Scientific Scimed, Inc. | 2012-11-05 |
| INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S311) | Boston Scientific Corp | 2012-11-05 |
| CRT-D MODELS: INCEPTA N160, N161, N164, ENERGEN N140, N141, PUNCTUA N050 (P010012/S310) | Boston Scientific Corp | 2012-11-05 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S031) | Boston Scientific Corp | 2012-11-05 |
| ICD MODELS, INCEPTA E-160, E-161, E162, E163, ENERGEN E140, E141, E142, E143, PUNCTUA E050, E050, E051, E052, E053 (P960040/S277) | Boston Scientific | 2012-11-05 |
| CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S050) | Corcym S.r.l. | 2012-11-05 |
| ENDOTAK LEAD SYSTEM (P910073/S108) | Boston Scientific | 2012-11-05 |
| INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S278) | Boston Scientific | 2012-11-05 |
| EXPRESS LD MONORAIL ILIAC PREMOUNTED STENT SYSTEM (P090003/S014) | Boston Scientific Corporation | 2012-11-05 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P110010/S031) | Boston Scientific Corp | 2012-11-05 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S093) | Boston Scientific Corp | 2012-11-05 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P100023/S056) | Boston Scientific Corp | 2012-11-05 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S005) | William Cook Europe Aps | 2012-11-05 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S040) | Medtronic Cardiac Rhythm Disease Management | 2012-11-02 |
| CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,MAXIMO II CRT-D,MAXIMO II DF4 CRT-D,PROTECTA CRT-D,PROTECTA DF4 CRT-D (P010031/S336) | Medtronic Cardiac Rhythm Disease Management | 2012-11-02 |
| MAXIMO II DF4CRT-D,MAXIMO II DF4 ICD,MAXIMO II ICD,PROTECTA DF4 ICD,PROTECTA ICD,PROTECTA XT DF4 ICD,PROTECTA XT ICD (P980016/S384) | Medtronic Cardiac Rhythm Disease Management | 2012-11-02 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P110019/S035) | Abbott Vascular | 2012-11-02 |
| VISION AND ML8 CORONARY STENT SYSTEMS (P020047/S052) | Abbott Vascular | 2012-11-02 |
| ULTRA AND ZETA RX CORONARY STENT SYSTEMS (P970020/S076) | Abbott Vascular, Inc. | 2012-11-02 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S102) | Abbott Vascular, Inc. | 2012-11-02 |
| LIFEVEST WAERABLE DEFIBRILLATOR (P010030/S031) | Zoll Manufacturing Corporation | 2012-11-02 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S078) | ABBOTT MEDICAL | 2012-11-01 |
| EPIC VALVE (P040021/S020) | ABBOTT MEDICAL | 2012-11-01 |
| TRIFECA HEART VALVE (P100029/S008) | ABBOTT MEDICAL | 2012-11-01 |
| WALLSTENT ENDO (TIPS) STENT SYSTEM (P930031/S037) | Boston Scientific Corp | 2012-10-31 |
| SPECTRANETICS LASER SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH (P960042/S042) | Spectranetics (Philips) | 2012-10-31 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S094) | Boston Scientific Scimed, Inc. | 2012-10-31 |
| TAXUS LIBERTE CORONARY STENT SYSTEM (P060008/S098) | Boston Scientific Corp | 2012-10-31 |
| ATLAS+HF, ATLAS II, HF, ATLAS II+ HF, EPIC + EPIC HF, EPIC + EPIC II HF, EPIC II + HF, PROMOTE, PROMOTE + PROMOTE RF, PR (P030054/S235) | ABBOTT MEDICAL | 2012-10-31 |
| WALLSTENT ENDO (VENOUS) STENT SYTEM (P980033/S026) | Boston Scientific Corporation | 2012-10-31 |
| FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-PS (P030035/S105) | ABBOTT MEDICAL | 2012-10-31 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S035) | Boston Scientific Corp | 2012-10-31 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S181) | Medtronic, Inc. | 2012-10-31 |
| REVO MRI IPG (P090013/S076) | Medtronic, Inc. | 2012-10-31 |
| ADVISA DR IPG (P980035/S295) | Medtronic, Inc. | 2012-10-31 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S099) | Boston Scientific Scimed, Inc. | 2012-10-31 |
| ATLAS/ATLAS+, ATLAS II/ATLAS 11+ CURRENT, CURRENT ACCEL, CURRENT+ EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY, FORTFY ASSURA, (P910023/S306) | ABBOTT MEDICAL | 2012-10-31 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S016) | Biosense Webster, Inc. | 2012-10-31 |
| WALLSTENT REDUCED PROFILE STENT SYSTEM (P940019/S032) | Boston Scientific Scimed, Inc. | 2012-10-31 |
| IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DE PACERS (P880086/S227) | ABBOTT MEDICAL | 2012-10-31 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S056) | Boston Scientific Corp | 2012-10-31 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S008) | Medtronic Vascular | 2012-10-26 |
| ENTRUST,SECURA,GEM II/III VR/DR,INTRINSIC/INTRINSIC 30,MAXIMO VR/DR,MAXIMO II,MARQUIS VR/DR,PROTECTA/PROTECTA XT (P980016/S376) | Medtronic Cardiac Rhythm Disease Management | 2012-10-26 |
| CONCERTA, CONSULTA/CONSULTA DF4, & VARIOUS INSYNC FAMILIES OF ICD'S; CONCERTO II, MAXIMO II,PROTECTA,PROTECTA XT CRT-D'S (P010031/S329) | Medtronic Cardiac Rhythm Disease Management | 2012-10-26 |
| GEM III AT (P980050/S076) | Medtronic, Inc. | 2012-10-26 |
| CAPSURE, VITATRON CRYSTALINE, VITATRON EXCELLENCE PS (P830061/S080) | Medtronic Cardiac Rhythm Disease Management | 2012-10-26 |
| ATS 3F AORTIC BIOPROSTHESIS (P060025/S009) | Medtronic, Inc. | 2012-10-26 |
| ATTAIN STARFIX LEAD (P060039/S038) | Medtronic, Inc. | 2012-10-25 |
| TRANSVENE LEAD (P980050/S078) | Medtronic, Inc. | 2012-10-25 |
| CAPSUREFIX MRI LEAD (P090013/S075) | Medtronic, Inc. | 2012-10-25 |
| AATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD (P010015/S180) | Medtronic, Inc. | 2012-10-25 |
| CAPSURE LEADS (P890003/S261) | Medtronic, Inc. | 2012-10-25 |
| ATTAIN ABILITY LEADS (P080006/S045) | Medtronic, Inc. | 2012-10-25 |
| CAPSURE LEADS, VITATRON CRYSTALINE LEADS, VITATRON EXCELLENCE PS+ LEADS (P830061/S079) | Medtronic Cardiac Rhythm Disease Management | 2012-10-25 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S049) | Medtronic Cardiac Rhythm Disease Management | 2012-10-25 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE (P930039/S075) | Medtronic, Inc. | 2012-10-25 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC LEAD, TUNNELLING TOOL (P920015/S097) | Medtronic, Inc. | 2012-10-25 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S045) | Medtronic, Inc. | 2012-10-25 |