| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT (P980016/S414) | Medtronic Cardiac Rhythm Disease Management | 2013-05-14 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S049) | W. L. Gore & Associates, Inc. | 2013-05-14 |
| CADENCE, CADET, CONTOUR, CONTOUR 11/MD, ADGSTROM II/MD, PROFILEII/MD, PHOTON, PHOTON MICRO (P910023/S314) | ABBOTT MEDICAL | 2013-05-14 |
| BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S374) | Medtronic Cardiac Rhythm Disease Management | 2013-05-14 |
| EPIC HF, EPIC + HR, EPIC II HF, EPIC II+ HF, ATLAS HF, ATLAS+HF, ATLAS II +HF, ATLAS, PROMOTE, PROMOTE + (P030054/S245) | ABBOTT MEDICAL | 2013-05-14 |
| REVO MRI SURESCAN PACKING SYSTEM (P090013/S092) | Medtronic, Inc. | 2013-05-14 |
| ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S322) | Medtronic, Inc. | 2013-05-14 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S009) | Cordis US Corporation | 2013-05-09 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S048) | Cook, Inc. | 2013-05-09 |
| PARADYM RF CRT-D (P060027/S038) | MicroPort CRM USA, Inc. | 2013-05-09 |
| PARADYM RF VR ICDS (P980049/S071) | MicroPort CRM USA, Inc. | 2013-05-09 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S005) | Boston Scientific Corporation | 2013-05-09 |
| BELOS VR-T (P980023/S052) | Biotronik, Inc. | 2013-05-08 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S064) | Medtronic, Ireland | 2013-05-08 |
| PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T (P950037/S121) | Biotronik, Inc. | 2013-05-08 |
| BELOS DR-T,BELOS A+-T,LEXOS DR-T/LEXOS VR-T,XELOS DR-T,LUMOS DR-T/LUMOS VR-T (P000009/S054) | Biotronik, Inc. | 2013-05-08 |
| LUMAX 300 DR-T/LUMAX 340 DR-T,LUMAX 300 VR-T/LUMAX 340 VR-T,LUMAX 500 DR-T/LUMAX 540 DR-T,LUMAX 500 VR-T/LUMAX 540 VR-T, (P050023/S063) | Biotronik, Inc. | 2013-05-08 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S010) | Medtronic Vascular | 2013-05-08 |
| STRATOS LV-T,EVIA HF-T (P070008/S041) | Biotronik, Inc. | 2013-05-08 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S074) | Medtronic, Inc. | 2013-05-08 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S371) | Medtronic Cardiac Rhythm Disease Management | 2013-05-07 |
| FLEXTEND LEAD (P960006/S038) | Boston Scientific | 2013-05-07 |
| ADVISA MRI (P980035/S318) | Medtronic, Inc. | 2013-05-07 |
| RELIANCE IS-1/DF-1 LEAD AND RELIANCE 4-SITE LEAD (P910073/S116) | Boston Scientific | 2013-05-07 |
| HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (P060040/S023) | ABBOTT MEDICAL | 2013-05-07 |
| EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR (P980016/S410) | Medtronic Cardiac Rhythm Disease Management | 2013-05-07 |
| EVERA S DR, EVERA S VR, EVERA XT DR (P980016/S408) | Medtronic Cardiac Rhythm Disease Management | 2013-05-03 |
| CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,VIVA S (P010031/S370) | Medtronic Cardiac Rhythm Disease Management | 2013-05-03 |
| PARADYM CRT-D, PARADYM RF CRT-D (P060027/S050) | MicroPort CRM USA, Inc. | 2013-05-03 |
| PARADYM VR AND DR, PARADYM RF VR AND DR (P980049/S082) | MicroPort CRM USA, Inc. | 2013-05-03 |
| EVERA S DR, EVERA S VR, EVERA XT DR (P980016/S409) | Medtronic Cardiac Rhythm Disease Management | 2013-05-03 |
| INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS (P980016/S407) | Medtronic Cardiac Rhythm Disease Management | 2013-05-03 |
| ENDURANT II STENT GRAFT SYSTEM (P100021/S024) | Medtronic Vascular | 2013-05-03 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S011) | Medtronic Vascular | 2013-05-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S048) | W. L. Gore & Associates, Inc. | 2013-05-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S029) | W. L. Gore & Associates, Inc. | 2013-05-02 |
| GORE TAG THORACIC ENDOPROSTHESEIS (P040043/S052) | W. L. Gore & Associates, Inc. | 2013-05-02 |
| TALENT AAA STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM (P070027/S036) | Medtronic Vascular | 2013-05-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S081) | W. L. Gore & Associates, Inc. | 2013-05-02 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S037) | Medtronic Vascular | 2013-05-02 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S025) | Medtronic Vascular | 2013-05-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S097) | Boston Scientific Corp | 2013-05-01 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S131) | Boston Scientific | 2013-04-30 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S040) | Medtronic, Inc. | 2013-04-30 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S369) | Medtronic Cardiac Rhythm Disease Management | 2013-04-30 |
| HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S040) | Medtronic, Inc. | 2013-04-30 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S019) | Medtronic, Inc. | 2013-04-30 |
| PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICD'S (P960040/S293) | Boston Scientific | 2013-04-30 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S406) | Medtronic Cardiac Rhythm Disease Management | 2013-04-30 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S007) | Boston Scientific Corporation | 2013-04-30 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT, MODEL 150 (P790007/S036) | Medtronic Heart Valves | 2013-04-30 |
| PUNCTUA, COGNIS, ENERGEN, INCEPTA CRT-D'S (P010012/S328) | Boston Scientific Corp | 2013-04-30 |
| MOSAIC PORCINE BIOPROSTHESIS, MODELS 305 AND 310 (P990064/S048) | Medtronic, Inc. | 2013-04-30 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S031) | Bard Peripheral Vascular | 2013-04-29 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S030) | W. L. Gore & Associates, Inc. | 2013-04-29 |
| PUNCTUA, COGNIS, ENERGEN, AND INCEPTA CRT-DS (P010012/S325) | Boston Scientific Corp | 2013-04-26 |
| PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S290) | Boston Scientific | 2013-04-26 |
| PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S292) | Boston Scientific | 2013-04-26 |
| INCEPTA,ENERGEN,PUNCTUA,COGNIS CRT-DS (P010012/S327) | Boston Scientific Corp | 2013-04-26 |
| EVERA S DR (P980016/S411) | Medtronic Cardiac Rhythm Disease Management | 2013-04-26 |
| CELCIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAV DS CATHETER (P010068/S033) | Biosense Webster, Inc. | 2013-04-25 |
| BIOSENSE WEBSTER CABLES (P990071/S022) | Biosense Webster, Inc. | 2013-04-25 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY SYSTEM, XIENC (P110019/S041) | Abbott Vascular | 2013-04-25 |
| NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHETER (P040036/S035) | Biosense Webster, Inc. | 2013-04-25 |
| CELCIUS CATHETER,CELCIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER,DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,B (P950005/S043) | Biosense Webster, Inc. | 2013-04-25 |
| CELCIUS THERMOCOOL CATHETER, CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL (P030031/S051) | Biosense Webster, Inc. | 2013-04-25 |
| NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES (P990025/S036) | Biosense Webster, Inc. | 2013-04-25 |
| INVIVE CARDIAC RESYNCHRONIZATION THERAPY -PACEMAKER (CRT-P) (P030005/S097) | Guidant Corp. | 2013-04-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S023) | Edwards Lifesciences, LLC | 2013-04-24 |
| DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING (P870077/S053) | Edwards Lifesciences, LLC | 2013-04-24 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S042) | Edwards Lifesciences, LLC | 2013-04-24 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S049) | Cook, Inc. | 2013-04-24 |
| PORCINE AORTIC BIOPROTHESIS AND PORCINE MITRAL BIOPROSTHESIS (P870056/S058) | Edwards Lifesciences, LLC | 2013-04-24 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S107) | Edwards Lifesciences, LLC | 2013-04-24 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S040) | Edwards Lifesciences, LLC | 2013-04-24 |
| TRANSCATHETER HEART VALVE (P110021/S009) | Edwards Lifesciences, LLC | 2013-04-24 |
| ATLAS/ATLAS+, ATLAS II/ATLAS II+, CURRENT, CURRENT ACCEL, CURRENT+, EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY (P910023/S312) | ABBOTT MEDICAL | 2013-04-23 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S010) | Medtronic | 2013-04-23 |
| IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES (P880086/S231) | ABBOTT MEDICAL | 2013-04-23 |
| FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-P DEVICES (P030035/S109) | ABBOTT MEDICAL | 2013-04-23 |
| ATLAS+ HF/ATLAS II HF, ATLAS II+ HF, EPIC+, EPIC II HF, EPIC II+HF, PROMOTE, PROMOTE+, PROMOTE, RF, PROMOTE ACCEL, UNIFY (P030054/S242) | ABBOTT MEDICAL | 2013-04-23 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S038) | Bard Peripheral Vascular, Inc. | 2013-04-22 |
| BARD E-LUMINEXX VASCULAR STENT SYSTEM (P080007/S016) | Bard Peripheral Vascular, Inc. | 2013-04-22 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S030) | Bard Peripheral Vascular | 2013-04-22 |
| OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S003) | Endologix, LLC | 2013-04-21 |
| INCEPTA, ENERGEN, AND PUNCTUA MODELS OF ICD¿S (P960040/S289) | Boston Scientific | 2013-04-19 |
| INCEPTA, ENERGEN, AND PUNCTUA MODELS OF CRT¿S (P010012/S324) | Boston Scientific Corp | 2013-04-19 |
| 6947M SPRINT QUATTRO LEAD (P920015/S105) | Medtronic, Inc. | 2013-04-18 |
| 3830 SELECTSECURE LEAD (P030036/S054) | Medtronic Cardiac Rhythm Disease Management | 2013-04-18 |
| ATTAIN STARFIX LEAD (P060039/S042) | Medtronic, Inc. | 2013-04-18 |
| CAPSURE LEAD, CAPSURE SENSE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S087) | Medtronic Cardiac Rhythm Disease Management | 2013-04-18 |
| WALLSTENT (ILIAC) ENDOPROSTHESIS (P940019/S036) | Boston Scientific Scimed, Inc. | 2013-04-18 |
| BLAZERII TEMPERATURE ABLATION CATHETER, BLAZERII XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATION (P020025/S040) | Boston Scientific | 2013-04-18 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD (P980016/S405) | Medtronic Cardiac Rhythm Disease Management | 2013-04-18 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S057) | Boston Scientific Corp | 2013-04-18 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD (P930039/S083) | Medtronic, Inc. | 2013-04-18 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S046) | W. L. Gore & Associates, Inc. | 2013-04-18 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S042) | Boston Scientific Corp | 2013-04-18 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S011) | Boston Scientific Corp | 2013-04-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S010) | Edwards Lifesciences, LLC | 2013-04-18 |