| ENDURANT STENT GRAFT SYSTEM (P100021/S034) | Medtronic Vascular | 2014-05-06 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S035) | ABBOTT MEDICAL | 2014-05-06 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM (P100040/S019) | Medtronic Vascular | 2014-05-06 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S138) | Boston Scientific Corp | 2014-05-05 |
| XELOS DR-T ICD'S (P000009/S057) | Biotronik, Inc. | 2014-05-04 |
| ENTOVIS PROMRI PACEMAKER SYSTEM (P950037/S132) | Biotronik, Inc. | 2014-05-04 |
| ILESTO ICD'S AND CRT-D'S (P050023/S074) | Biotronik, Inc. | 2014-05-04 |
| EVIA CRT-P'S (P070008/S050) | Biotronik, Inc. | 2014-05-04 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S480) | Medtronic Cardiac Rhythm Disease Management | 2014-05-02 |
| AID-B/BR AND VENTAK ICD (P830060/S077) | Boston Scientific | 2014-05-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S093) | W. L. Gore & Associates, Inc. | 2014-05-02 |
| BRAVACRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S441) | Medtronic Cardiac Rhythm Disease Management | 2014-05-02 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S039) | Medtronic Vascular | 2014-05-02 |
| CONTAK RENEWAL TR, INVIVE, INTUA FAMILIES OF CRT-PS (P030005/S106) | Guidant Corp. | 2014-05-02 |
| MYCARELINK PATIENT MONITOR (P890003/S308) | Medtronic, Inc. | 2014-05-02 |
| PULSAR, PULSAR MAX, DISCOVER, INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO FAMILIES OF PACEMAKER (N970003/S159) | Boston Scientific Corp | 2014-05-02 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S077) | Medtronic, Ireland | 2014-05-02 |
| VENTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF CRT-DS (P010012/S347) | Boston Scientific Corp | 2014-05-02 |
| VENTAK PRX, VENTAK MINI FAMILIES OF ICDS (P910077/S141) | Boston Scientific | 2014-05-02 |
| VIGOR, MERIDIAN, DISCOVER FAMILIES OF PACEMAKER (P940031/S076) | Boston Scientific | 2014-05-02 |
| VENTAK AV, VENTAK PRIZM, VITALITY, CONFIENT, TELIGEN, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF ICDS (P960040/S310) | Boston Scientific | 2014-05-02 |
| ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS (P910073/S124) | Boston Scientific | 2014-05-02 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PALTINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIR (P110010/S080) | Boston Scientific Corp | 2014-05-01 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S059) | Boston Scientific Corp | 2014-05-01 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S137) | Boston Scientific Corp | 2014-05-01 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P100023/S095) | Boston Scientific Corp | 2014-05-01 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S127) | Boston Scientific Scimed, Inc. | 2014-05-01 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S069) | Boston Scientific Corp | 2014-05-01 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S002) | Medinol, Ltd. | 2014-05-01 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S079) | Boston Scientific Corp | 2014-05-01 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S121) | Boston Scientific Scimed, Inc. | 2014-05-01 |
| MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES (P040044/S053) | Cordis US Corporation | 2014-05-01 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S039) | Edwards Lifesciences, LLC | 2014-05-01 |
| PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICD'S (P960040/S313) | Boston Scientific | 2014-05-01 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S094) | Boston Scientific Corp | 2014-05-01 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S049) | Boston Scientific Corp | 2014-05-01 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S057) | Boston Scientific | 2014-05-01 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S052) | Edwards Lifesciences, LLC | 2014-05-01 |
| PUNCTUA, COGNIS, ENERGY, & INCEPTA CRT-D'S (P010012/S350) | Boston Scientific Corp | 2014-05-01 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S123) | Edwards Lifesciences, LLC | 2014-05-01 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S001) | Cardiva Medical, Inc. | 2014-04-30 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S052) | Cordis US Corporation | 2014-04-30 |
| REVEAL LINQ SOFTWARE MODEL SWO26 (P890003/S304) | Medtronic, Inc. | 2014-04-30 |
| REPEL-CV BIORESORBABLE ADHESION BARRIER (P070005/S003) | Pathfinder Cell Therapy, Inc. | 2014-04-30 |
| VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM (P100040/S017) | Medtronic Vascular | 2014-04-30 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S001) | Abbott Vascular (Idef Technologies Inc) | 2014-04-30 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL (P860057/S122) | Edwards Lifesciences, LLC | 2014-04-30 |
| INVIVE AND INTUA CRT PS (P030005/S108) | Guidant Corp. | 2014-04-29 |
| CAMERON HEALTH SUBSUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S031) | Boston Scientific Corporation | 2014-04-29 |
| ADVANTIO, INGENIO, VITALIO AND FORMIO PACEMAKERS (N970003/S161) | Boston Scientific Corp | 2014-04-29 |
| THERAPY CATHETER (NON-IRRIGATED) (P040014/S022) | Irvine Biomedical, Inc. | 2014-04-28 |
| THERAPY COOL PATH DUO CATHETER (12 HOLE IRRIGATED), SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED), COOL PATH DUO ABLATION C (P110016/S011) | ABBOTT MEDICAL | 2014-04-28 |
| LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED) (P960016/S045) | St Jude Medical | 2014-04-28 |
| THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO (P040042/S027) | Irvine Biomedical,Inc.(Ibi) | 2014-04-28 |
| THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY (P060019/S027) | Irvine Biomedical, Inc. | 2014-04-28 |
| CAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S032) | Boston Scientific Corporation | 2014-04-28 |
| LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S031) | Boston Scientific Corporation | 2014-04-24 |
| ENRHYTHM MRI EMDRO1; REVO MRI RVDRO1 (P090013/S132) | Medtronic, Inc. | 2014-04-24 |
| MARQUIS DR 7274; MARQUIS VR 7230B/7230X/723E; MAXIMO DR7278; MAXIMO VR 7232 (P980016/S468) | Medtronic Cardiac Rhythm Disease Management | 2014-04-24 |
| ASSURITY, ASSURITY +, AND ENDURITY OF PACEMAKER DEVICES (P880086/S241) | ABBOTT MEDICAL | 2014-04-24 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S051) | Cordis US Corporation | 2014-04-24 |
| PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S096) | Boston Scientific Corp | 2014-04-24 |
| RELIANCE IS-1/DF-1 LEAD FAMILY,RELIANCE 4-SITE LEAD FAMILY (P910073/S123) | Boston Scientific | 2014-04-24 |
| ACUITY SPIRAL, EASYTRAK 2, EASYTRAK 3 (P010012/S345) | Boston Scientific Corp | 2014-04-24 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S136) | Boston Scientific Corp | 2014-04-24 |
| FLEXTEND (P960006/S041) | Boston Scientific | 2014-04-24 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S122) | Boston Scientific Scimed, Inc. | 2014-04-24 |
| ACUITY STEERABLE (P050046/S023) | Guidant Corp. | 2014-04-24 |
| PROMUS ELEMENT PLUS PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S081) | Boston Scientific Corp | 2014-04-24 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S128) | Boston Scientific Scimed, Inc. | 2014-04-24 |
| ALLURE AND ALLURE QUADRA FAMILIES OF CRT-P DEVICES (P030035/S119) | ABBOTT MEDICAL | 2014-04-24 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S048) | Boston Scientific Corp | 2014-04-23 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S058) | Boston Scientific Corp | 2014-04-23 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S035) | Bard Peripheral Vascular | 2014-04-23 |
| VIRTUOSO DR, VIRTUOSO VR, SECURA DR AND MAXIMO II DR (P980016/S398) | Medtronic Cardiac Rhythm Disease Management | 2014-04-23 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S068) | Boston Scientific Corp | 2014-04-23 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S056) | Boston Scientific | 2014-04-23 |
| OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S009) | Endologix, LLC | 2014-04-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S078) | Boston Scientific Corp | 2014-04-23 |
| EXOSEAL VASCULAR CLOSURE DEVICE (VCD) (P100013/S010) | Cordis US Corporation | 2014-04-23 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S043) | Bard Peripheral Vascular, Inc. | 2014-04-23 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S126) | Boston Scientific Scimed, Inc. | 2014-04-23 |
| EXPRESS 2 MONORAIL AND OVER THE WIRE (P020009/S120) | Boston Scientific Scimed, Inc. | 2014-04-23 |
| ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S135) | Boston Scientific Corp | 2014-04-23 |
| MEDTRONIC REMOTE HOME MONITOR (P890003/S268) | Medtronic, Inc. | 2014-04-23 |
| CONSULTA CRT-D, MAXIMO II CRT-D, CONCERTO 11 CRT-D, CPMCERTP CRT-D (P010031/S361) | Medtronic Cardiac Rhythm Disease Management | 2014-04-23 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, SV (P110019/S047) | Abbott Vascular | 2014-04-23 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S020) | Bard Peripheral Vascular, Inc. | 2014-04-23 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S093) | Boston Scientific Corp | 2014-04-23 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S090) | MicroPort CRM USA, Inc. | 2014-04-21 |
| PARADYM VR 8750, PARADYM DR 8750,PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), (P980049/S096) | MicroPort CRM USA, Inc. | 2014-04-21 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101),PARADYM RF CRT-D9750 (ZL102) (P060027/S063) | MicroPort CRM USA, Inc. | 2014-04-21 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL (P060038/S017) | Corcym Canada Corp | 2014-04-18 |
| INTERGRITY CORONARY STENT SYSTEMS (P030009/S076) | Medtronic, Ireland | 2014-04-17 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM OVER THE WIRE (P100023/S092) | Boston Scientific Corp | 2014-04-17 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 (P060027/S061) | MicroPort CRM USA, Inc. | 2014-04-17 |
| SPECTRANETICS LASER SHEATHS (SLS) (P960042/S048) | Spectranetics (Philips) | 2014-04-17 |
| PARADYM VR/DR, PARADYM RF VR/RF DR (P980049/S094) | MicroPort CRM USA, Inc. | 2014-04-17 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S007) | Medtronic, Ireland | 2014-04-17 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S038) | Edwards Lifesciences, LLC | 2014-04-17 |