| GORE HELEX SEPTAL OCCLUDER (P050006/S026) | W. L. Gore & Associates, Inc. | 2011-10-28 |
| XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S081) | Abbott Vascular, Inc. | 2011-10-28 |
| VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS (P020047/S040) | Abbott Vascular | 2011-10-28 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S025) | Boston Scientific Corp | 2011-10-28 |
| MULTILINK ZETA & ULTRA CORONARY STENT SYSTEMS (P970020/S069) | Abbott Vascular, Inc. | 2011-10-28 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S026) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S043) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S066) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S023) | Bard Peripheral Vascular, Inc. | 2011-10-27 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY SYSTEM (P100023/S023) | Boston Scientific Corp | 2011-10-27 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S022) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S025) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S036) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S024) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S038) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S015) | Spectranetics Corp. | 2011-10-27 |
| TELIGEN ICDS (P010012/S272) | Boston Scientific Corp | 2011-10-26 |
| LIFESTENT SOLO VASCULAR STENT SYSTEM (P070014/S026) | Bard Peripheral Vascular, Inc. | 2011-10-26 |
| COGNIS CRT-D (P960040/S246) | Boston Scientific | 2011-10-26 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S030) | Zoll Manufacturing Corporation | 2011-10-26 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011) | Medtronic, Ireland | 2011-10-26 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW) (P100023/S002) | Boston Scientific Corp | 2011-10-25 |
| ENDEAVOR SPRINT ZOTARLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S066) | Medtronic, Inc. | 2011-10-25 |
| CVX EXCIMER LASER SYSTEMS (P910001/S049) | Spectranetics Corp. | 2011-10-25 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S042) | W. L. Gore & Associates, Inc. | 2011-10-24 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S065) | W. L. Gore & Associates, Inc. | 2011-10-24 |
| PRODIGY (P890003/S236) | Medtronic, Inc. | 2011-10-21 |
| AMPLATZER SEPTAL OCCLUDER, AMPLATZER 45 DELIVERY AND EXCHANGE SYSTEMS (PTFE) (P000039/S042) | ABBOTT MEDICAL | 2011-10-21 |
| INSYNC III (P010015/S140) | Medtronic, Inc. | 2011-10-21 |
| 350 SERIES/ADAPTA/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA (P980035/S243) | Medtronic, Inc. | 2011-10-21 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S019) | ABBOTT MEDICAL | 2011-10-21 |
| AMPLATZER DUCT OCCLUDER, AMPLATZER 180 DELIVERY AND EXCHANGE SYSTEMS (PTFE) (P020024/S034) | ABBOTT MEDICAL | 2011-10-21 |
| VITATRON DA+ C & T SERIES IPGS (P990001/S097) | Medtronic, Inc. | 2011-10-21 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S021) | W. L. Gore & Associates, Inc. | 2011-10-21 |
| MERLIN PATIENT CARE SYSTEM MODEL 3650 (P030054/S200) | ABBOTT MEDICAL | 2011-10-20 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S240) | ABBOTT MEDICAL | 2011-10-20 |
| EPIC/ATLAS/ PROMOTE FAMILY OF CRT-DS (P030054/S159) | ABBOTT MEDICAL | 2011-10-20 |
| ENDEAVOR SPRINT CORONARY STENT SYSTEMS (P060033/S068) | Medtronic, Inc. | 2011-10-19 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S023) | W. L. Gore & Associates, Inc. | 2011-10-19 |
| TAXUS LIBERTE OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S079) | Boston Scientific Corp | 2011-10-19 |
| DRIVER & MICRO DRIVER CORONARY STENT SYSTEMS (P030009/S060) | Medtronic, Ireland | 2011-10-19 |
| TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM (P070007/S032) | Medtronic Vascular | 2011-10-19 |
| EXPRESS & EXPRESS2 CORONARY STENT SYSTEMS (P020009/S078) | Boston Scientific Scimed, Inc. | 2011-10-19 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S022) | Boston Scientific Corp | 2011-10-19 |
| TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT SYSTEM & TALENT CONVERTER STENT GRAFT WITH THE XCELERANT SYSTEM (P070027/S033) | Medtronic Vascular | 2011-10-19 |
| TRIFECTA VALVE (P100029/S009) | ABBOTT MEDICAL | 2011-10-19 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S024) | Boston Scientific Corp | 2011-10-19 |
| VERIFLEX (FORMERLY LIBERTE) OTW BARE METAL CORONARY STENT SYSTEM (P040016/S079) | Boston Scientific Scimed, Inc. | 2011-10-19 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S068) | Terumo Medical Corporation | 2011-10-18 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S078) | Boston Scientific Scimed, Inc. | 2011-10-14 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S021) | Boston Scientific Corp | 2011-10-14 |
| SUSTAIN XL SC, DC, SR, DR PACEMAKER MODELS PM1134, PM2134, PM1136, PM2136 (P880086/S210) | ABBOTT MEDICAL | 2011-10-14 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S077) | Boston Scientific Corp | 2011-10-14 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S078) | Boston Scientific Corp | 2011-10-14 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA (P980035/S241) | Medtronic, Inc. | 2011-10-13 |
| VITATRON DA+ C SERIES & VITATRO DA+ T SERIES IPG (P990001/S095) | Medtronic, Inc. | 2011-10-13 |
| REVO MRI (P090013/S039) | Medtronic, Inc. | 2011-10-13 |
| CONSULTA CRT-P & SYNCRA CRT-P (P010015/S138) | Medtronic, Inc. | 2011-10-13 |
| TRIFECTA VALVE (P100029/S004) | ABBOTT MEDICAL | 2011-10-13 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/VIRTUOSO II (P980016/S322) | Medtronic Cardiac Rhythm Disease Management | 2011-10-13 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S020) | W. L. Gore & Associates, Inc. | 2011-10-13 |
| CONCERTO/CONCERTO II/CONSULTA/INSYNC II & III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO PROTECTA/PROTECTA XT (P010031/S276) | Medtronic Cardiac Rhythm Disease Management | 2011-10-13 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT (P020052/S008) | St Jude Medical | 2011-10-13 |
| BIOCOR & EPIC VALVES (P040021/S018) | ABBOTT MEDICAL | 2011-10-13 |
| CADENCE FAMILY OF ICDS (P910023/S275) | ABBOTT MEDICAL | 2011-10-12 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S203) | ABBOTT MEDICAL | 2011-10-12 |
| NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/EZ STEER THERMOCOOL NAV CATHETERS (P040036/S026) | Biosense Webster, Inc. | 2011-10-07 |
| INTERFACE CABLES (P990071/S015) | Biosense Webster, Inc. | 2011-10-07 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S024) | Bard Peripheral Vascular, Inc. | 2011-10-07 |
| CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES (P950005/S035) | Biosense Webster, Inc. | 2011-10-07 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S201) | ABBOTT MEDICAL | 2011-10-07 |
| CADENCE FAMILY OF ICDS (P910023/S274) | ABBOTT MEDICAL | 2011-10-07 |
| NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR CATHETERS/INTERFACE CABLES (P990025/S029) | Biosense Webster, Inc. | 2011-10-07 |
| CELSIUS & NAVISTAR DS CATHETER/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR DS CATHETER/INTERFACE CABLES (P010068/S025) | Biosense Webster, Inc. | 2011-10-07 |
| FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S040) | Medtronic Cryocath, LP | 2011-10-07 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER (P100010/S012) | Medtronic Cryocath, LP | 2011-10-07 |
| CELSIUS THERMOCOOL/CELSIUS RMT THERMOCOOL/NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/NAV CATHETERS (P030031/S035) | Biosense Webster, Inc. | 2011-10-07 |
| TENDRIL FAMILY OF LEADS (P960013/S067) | ABBOTT MEDICAL | 2011-10-06 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S020) | Boston Scientific Corp | 2011-10-06 |
| MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY (P040044/S034) | Cordis US Corporation | 2011-10-04 |
| VISION & ML8 CORONARY STENT SYSTEM (P020047/S035) | Abbott Vascular | 2011-10-04 |
| MULTILINK ZETA CORONARY STENT SYSTEM (P970020/S064) | Abbott Vascular, Inc. | 2011-10-04 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S072) | Abbott Vascular, Inc. | 2011-10-04 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S067) | Medtronic, Inc. | 2011-09-30 |
| LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS (P000009/S046) | Biotronik, Inc. | 2011-09-30 |
| LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S046) | Biotronik, Inc. | 2011-09-30 |
| COROX OTW-L BP LEADS (P070008/S026) | Biotronik, Inc. | 2011-09-30 |
| EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S098) | Biotronik, Inc. | 2011-09-30 |
| PROTECTA/PROTECTA XT (P010031/S273) | Medtronic Cardiac Rhythm Disease Management | 2011-09-29 |
| AFX ACCESSORY STENT GRAFT DELIVERY SYSTEMS (P040002/S033) | Endologix, LLC | 2011-09-29 |
| PROTECTA/PROTECTA XT (P980016/S319) | Medtronic Cardiac Rhythm Disease Management | 2011-09-29 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S043) | ABBOTT MEDICAL | 2011-09-28 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S273) | ABBOTT MEDICAL | 2011-09-28 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S074) | St. Jude Medical, Inc. | 2011-09-28 |
| LEGOO (P110003) | Genzyme Corp. | 2011-09-28 |
| FRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PS (P030035/S088) | ABBOTT MEDICAL | 2011-09-28 |
| EPIC HF/ATLAS+HF/PROMOTE FAMILY OF CRT-DS (P030054/S199) | ABBOTT MEDICAL | 2011-09-28 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S209) | ABBOTT MEDICAL | 2011-09-28 |
| TAXUS LIBERTE OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S075) | Boston Scientific Corp | 2011-09-27 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S017) | Boston Scientific Corp | 2011-09-27 |