| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S241) | Medtronic, Inc. | 2014-07-11 |
| REVO MRI IPG (P090013/S144) | Medtronic, Inc. | 2014-07-11 |
| MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD AND MAXIMO VR ICD (P980016/S486) | Medtronic Cardiac Rhythm Disease Management | 2014-07-11 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S051) | Endologix, LLC | 2014-07-11 |
| NG3 ICDS, ORIGEN, INOGEN, DYNAGEN EL; NG2.5 ICDS -ORIGEN, INOGEN, DYNAGEN MINI ICDS (P960040/S321) | Boston Scientific | 2014-07-11 |
| NG3 CRT-D, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 (P010012/S360) | Boston Scientific Corp | 2014-07-11 |
| INSYNCC III MARQUIS ICD, INSYNC MAXIMO ICD (P010031/S448) | Medtronic Cardiac Rhythm Disease Management | 2014-07-11 |
| COROX, CELERITY (P070008/S052) | Biotronik, Inc. | 2014-07-11 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S055) | Medtronic, Inc. | 2014-07-11 |
| LIFE STENT VASCULAR STENT SYSTEM (P070014/S045) | Bard Peripheral Vascular, Inc. | 2014-07-11 |
| LINOX SMART SD, VIGILA, VOLTA (P980023/S059) | Biotronik, Inc. | 2014-07-11 |
| SPRINT QUATTRO LEAD (P920015/S132) | Medtronic, Inc. | 2014-07-10 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S004) | Abbott Vascular (Idef Technologies Inc) | 2014-07-10 |
| PROMOTE, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILIES OF CRT-D DEVICES (P030054/S271) | ABBOTT MEDICAL | 2014-07-10 |
| CURRENT, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILIES OF ICD DEVICE (P910023/S340) | ABBOTT MEDICAL | 2014-07-10 |
| ADVISA DR,ADVISA DR MRI (P980035/S358) | Medtronic, Inc. | 2014-07-09 |
| EVERA S DR ICD, EVERA S VR ICD; EVERA XT DR. ICD; EVERA XT VR IC D; MAXIMO II ICD; PROTECTA ICD' SECURA ICD, VIRTUOSO II (P980016/S488) | Medtronic Cardiac Rhythm Disease Management | 2014-07-09 |
| ANTHEM RFCRT-PS (P030035/S122) | ABBOTT MEDICAL | 2014-07-09 |
| MAXIMO II DR,MAXIMO II VR,VIRTUOSO II VR,SECURA DR,SECURA VR (P980016/S452) | Medtronic Cardiac Rhythm Disease Management | 2014-07-09 |
| EASYTRAK 2 IS-1 CORONARY VENOUS BIPOLAR PACE/SENSE LEADS (P010012/S362) | Boston Scientific Corp | 2014-07-09 |
| 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 (P010031/S450) | Medtronic Cardiac Rhythm Disease Management | 2014-07-09 |
| AFX ENDOVASULAR AAA SYSTEM (P040002/S052) | Endologix, LLC | 2014-07-09 |
| VIVA CRT-P,CONSULTA CRT-P,SYNCRA CRT-P (P010015/S227) | Medtronic, Inc. | 2014-07-09 |
| CARELINK ENORE PROGRAMMER,CARELINK 2090 PROGRAMMER,CARELINK HOME MONITOR,CARELINK EXPRESS MONITOR,CARDIOSIGHT READER,DEV (P890003/S297) | Medtronic, Inc. | 2014-07-09 |
| FOCAL CATHETERS (P020045/S056) | Medtronic Cryocath, LP | 2014-07-09 |
| CONCERTO II CRT-D,MAXIMO II CRT-D,CONSULTA CRT-D,CONSULTA CRT-D DF4,MAXIMO II CRT-D DF4 (P010031/S414) | Medtronic Cardiac Rhythm Disease Management | 2014-07-09 |
| ACCENT SR RF, ACCENT DR RF PACEMAKERS (P880086/S244) | ABBOTT MEDICAL | 2014-07-09 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S004) | ABBOTT MEDICAL | 2014-07-09 |
| BALLOON CATHETER (P100010/S038) | Medtronic Cryocath, LP | 2014-07-09 |
| INCEPTA, ENERGEN, PUCTUA, COGNIS, DYANAGEN, INOGEN, ORIGEN CRT-DS (P010012/S358) | Boston Scientific Corp | 2014-07-08 |
| CAPSUREFIX MRI LEAD (P090013/S145) | Medtronic, Inc. | 2014-07-08 |
| CAPSUREFIX NOVUS LEAD (P930039/S110) | Medtronic, Inc. | 2014-07-08 |
| INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN ICDS (P960040/S319) | Boston Scientific | 2014-07-08 |
| PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-DS,ORIGEN CRT-DS,INOGEN CRT-DS,DYNAGEN CRT-DS (P010012/S361) | Boston Scientific Corp | 2014-07-08 |
| INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO PACEMAKERS (N970003/S165) | Boston Scientific Corp | 2014-07-08 |
| INVIVE CRT-P, CONTAK RENEWAL TR CRT-P, INTUA CRT-P (P030005/S111) | Guidant Corp. | 2014-07-08 |
| ENDURANT AND ENDURANT II STENT GRAFT SYSTEM (P100021/S038) | Medtronic Vascular | 2014-07-08 |
| PUNCTUA ICDS,TELIGEN ICDS,ENERGEN ICDS,INCEPTA ICDS,ORIGEN ICDS,INOGEN ICDS,DYNAGEN ICDS (P960040/S322) | Boston Scientific | 2014-07-08 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S050) | Endologix, LLC | 2014-07-07 |
| VIVA QUAD XT CRT-D,VIVA QUAD S CRT-D,BRAVA QUAD CRT-D,VIVA QUAD C CRT-D,VIVA/BRAVA/EVERA SOFTWARE APPLICATION (P010031/S442) | Medtronic Cardiac Rhythm Disease Management | 2014-07-03 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S063) | Abbott Vascular | 2014-07-03 |
| PROTEGO FAMILY OF ICD LEADS (P980023/S057) | Biotronik, Inc. | 2014-07-03 |
| CARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA) (P890003/S309) | Medtronic, Inc. | 2014-07-03 |
| ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D (P050023/S076) | Biotronik, Inc. | 2014-07-03 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL (P110019/S068) | Abbott Vascular | 2014-07-03 |
| SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION) (P990071/S027) | Biosense Webster, Inc. | 2014-07-02 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S008) | Medtronic Vascular, Inc. | 2014-07-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S066) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S066) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S039) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S067) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S041) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S101) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S099) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S007) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S100) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S036) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S008) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S040) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHERTERS (P100010/S036) | Medtronic Cryocath, LP | 2014-07-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S037) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S009) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S098) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| CELSIUS CATHETER, CELSIUS RMT CATHETER (P950005/S050) | Biosense Webster, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S069) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S006) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S034) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S068) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S063) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S042) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S065) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S035) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S024) | Syncardia Systems, LLC | 2014-07-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S064) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| CELSIUS DS CATHETER, NAVISTAR DS CATHETER (P010068/S039) | Biosense Webster, Inc. | 2014-07-02 |
| NAVISTAR RMT THERMOCOOL, D-1266-XX, CELSIUS RMT THERMOCOOL D-1302 XX (P030031/S044) | Biosense Webster, Inc. | 2014-07-01 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM (P060001/S021) | Medtronic Vascular, Inc. | 2014-07-01 |
| NAVISTAR RMT THERMOCOOL CATHETER (P040036/S032) | Biosense Webster, Inc. | 2014-07-01 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S009) | Medtronic Vascular, Inc. | 2014-07-01 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTINGPLATINUM CHROMIUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM (P110010/S088) | Boston Scientific Corp | 2014-06-30 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S033) | Boston Scientific Corporation | 2014-06-30 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S130) | Boston Scientific Scimed, Inc. | 2014-06-30 |
| PRODIGY IPG (P890003/S310) | Medtronic, Inc. | 2014-06-30 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S101) | Boston Scientific Corp | 2014-06-30 |
| CVX-300 & CVX-300P EXCIMER LASER SYSTEM (P910001/S071) | Spectranetics Corp. | 2014-06-30 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S097) | W. L. Gore & Associates, Inc. | 2014-06-30 |
| VARIOUS MODELS OF SLX LEADS AND VARIOUS MODELS OF SELOX,DEXTRUS,AND SAFIO DRUG ELUTING LEADS (P950037/S134) | Biotronik, Inc. | 2014-06-30 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S124) | Boston Scientific Scimed, Inc. | 2014-06-30 |
| ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES (P910073/S126) | Boston Scientific | 2014-06-30 |
| VARIOUS MODELS OF COROX, CELERITY AND LV LEADS (P070008/S051) | Biotronik, Inc. | 2014-06-30 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S061) | Boston Scientific Corp | 2014-06-30 |
| KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS (P980023/S058) | Biotronik, Inc. | 2014-06-30 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S379) | Medtronic, Inc. | 2014-06-30 |
| PARADYM CRT-D & PARADYM RF CRT-D (P060027/S064) | MicroPort CRM USA, Inc. | 2014-06-27 |
| PARADYM RF VR 9250, VR9250, PARADYM RF DR 9550 (P980049/S098) | MicroPort CRM USA, Inc. | 2014-06-27 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S037) | Boston Scientific Corporation | 2014-06-27 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S051) | Boston Scientific Corp | 2014-06-27 |
| PARADYM VR ICD, DR ICD, RF VR ICD, RD DR ICD, ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS (P980049/S097) | MicroPort CRM USA, Inc. | 2014-06-27 |
| SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S039) | Boston Scientific Corporation | 2014-06-27 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S044) | Medtronic | 2014-06-27 |