| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S472) | Medtronic Cardiac Rhythm Disease Management | 2014-10-23 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S041) | Boston Scientific Corporation | 2014-10-23 |
| 7F FREEZOR CARDIAC CRYOABLATION CATH.& XTRA SURGICAL DEVICE, 9F FREEZOR MAX SURGICAL CATH CATHRYOCONSOLE SYSTEM (P020045/S060) | Medtronic Cryocath, LP | 2014-10-23 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S398) | Medtronic, Inc. | 2014-10-23 |
| ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER (P110021/S046) | Edwards Lifesciences, LLC | 2014-10-23 |
| PRECISE NITINOL STENT SYSTEM (P030047/S027) | Cordis US Corporation | 2014-10-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S014) | Edwards Lifesciences, LLC | 2014-10-23 |
| CORDIS SMART/SMART CONTROL VASCULAR STENT SYSTEM (P120002/S005) | Cordis US Corporation | 2014-10-23 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S508) | Medtronic Cardiac Rhythm Disease Management | 2014-10-23 |
| REPLY SR, REPLY DR, ESPIRIT SR, ESPRIT DR (P950029/S097) | MicroPort CRM USA, Inc. | 2014-10-23 |
| NOVAFLEX+ DELIVERY SYSTEM, ASCENDRA+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, ASCENDRA+ INTRODUCER SHE (P130009/S013) | Edwards Lifesciences, LLC | 2014-10-23 |
| TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P (P980040/S050) | Johnson & Johnson Surgical Vision, Inc. | 2014-10-23 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S056) | Integra LifeSciences Corporation | 2014-10-22 |
| MARGINPROBE SYSTEM (P110014/S004) | Dilon Medical Technologies, Ltd. | 2014-10-22 |
| MELAFIND (P090012/S003) | Strata Skin Sciences, Inc. | 2014-10-22 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S107) | Boston Scientific Corp | 2014-10-22 |
| EASY TRAK 2 FAMILY (P010012/S375) | Boston Scientific Corp | 2014-10-22 |
| PROMUS ELEMENT PLUS/PREMIER EVEROLIMUS-ELUTING CHROMIUM CORONARY STENT SYSTEM (P110010/S094) | Boston Scientific Corp | 2014-10-22 |
| REBEL PLATINUM CHROMINUM CORONARY STENT SYSTEM (P130030/S005) | Boston Scientific Corp | 2014-10-22 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S056) | Integra LifeSciences Corporation | 2014-10-22 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EECSS (P070015/S125) | Abbott Vascular, Inc. | 2014-10-22 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S005) | AtriCure, Inc. | 2014-10-22 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S039) | Integra Lifesciences Corp. | 2014-10-22 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; LL,; SV; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTE (P110019/S072) | Abbott Vascular | 2014-10-22 |
| COLLACOTE, COLLATAPE,COLLAPLUG ABSORBABLE COLLAGEN WOUND GRESSINGS FOR DENTAL SURGERY (P840062/S043) | Integra Lifesciences Corp. | 2014-10-22 |
| ZENITH (FLEX) AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S053) | Cook, Inc. | 2014-10-21 |
| ENTOVIS, EVIA, ESTELLA, EFFECTA, ECURO, DEXTRUS, SETROX, SELOX, TILDA, P-KIT, SAFIO, SLX, CARDIOMESSENGER LLT KIT, ICS (P950037/S141) | Biotronik, Inc. | 2014-10-21 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S074) | Boston Scientific Corp | 2014-10-21 |
| ALTRUA 2, ESSENTIO, PROPONENT AND ACCOLADE (N970003/S167) | Boston Scientific Corp | 2014-10-21 |
| GENESYS HTA SYSTEM (P000040/S033) | Axora Medical, Inc. | 2014-10-21 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITIORING SYSTEM (P120005/S018) | Dexcom, Inc. | 2014-10-21 |
| CAPSURE Z NOVUS LEAD; VITATRON IMPULSE II LEAD (P850089/S112) | Medtronic Cardiac Rhythm Disease Management | 2014-10-21 |
| NAVI-STAR RMT DS ELECTROPHYSIOLOGY CATHETER (P010068/S042) | Biosense Webster, Inc. | 2014-10-21 |
| EVIA HF-T, ENTOVIS HF-T, STRATOS LV, COROX OTW, CELERITY 2D,LV-KIT (P070008/S056) | Biotronik, Inc. | 2014-10-21 |
| ICS 3000/ RENAMIC PROGRAMMERS (P000009/S059) | Biotronik, Inc. | 2014-10-21 |
| INGENIO 2 CRT-P DEVICES AND INGENIO CRT-P DEVICES (P030005/S113) | Guidant Corp. | 2014-10-21 |
| CAPSUREFIX MRI LEAD (P090013/S160) | Medtronic, Inc. | 2014-10-21 |
| CAPSUREFIX MRI LEAD (P090013/S159) | Medtronic, Inc. | 2014-10-21 |
| ACRYSOF (P930014/S075) | Alcon Laboratories, Inc. | 2014-10-21 |
| REBEL PTCR CORONARY STENT SYSTEM (P130030/S004) | Boston Scientific Corp | 2014-10-21 |
| NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER (P990025/S041) | Biosense Webster, Inc. | 2014-10-21 |
| ATTAIN STARFIX LEAD (P060039/S064) | Medtronic, Inc. | 2014-10-21 |
| CELSIUS ELECTROPHYSIOLOGY CATHETER (P950005/S053) | Biosense Webster, Inc. | 2014-10-21 |
| BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P020025/S064) | Boston Scientific | 2014-10-21 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S144) | Medtronic, Inc. | 2014-10-21 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S067) | W. L. Gore & Associates, Inc. | 2014-10-21 |
| LINOX SMART SD, VIGILA 1CR, VOLTA 1CR, LINOX SMART S DX, PROTEGO SD (P980023/S062) | Biotronik, Inc. | 2014-10-21 |
| VITATRON BRILLIANT S+VDD LEAD (P890003/S322) | Medtronic, Inc. | 2014-10-21 |
| SUREFIX LEAD (P930039/S121) | Medtronic, Inc. | 2014-10-21 |
| CAPSURE SENSE LEAD (P830061/S116) | Medtronic Cardiac Rhythm Disease Management | 2014-10-21 |
| PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUARDA, PROMOTE RF PROMOTE+ QUADRA ASSURA, UNIFY, ASSURA, UNIFY QUADRA FAMILI (P030054/S275) | ABBOTT MEDICAL | 2014-10-21 |
| LLESTO 7 VR-T, IFORIA 7 VR-T, LLESTO 5 VR-T, IFORIA 5 VR-T, LUMAX 740 VR-T, LLESTO 7 DR-T, IFORIA 7 DR-T, LLESTO 5 DR-T (P050023/S080) | Biotronik, Inc. | 2014-10-21 |
| VITATRON EXCELLENCE PS+ LEAD (P830061/S117) | Medtronic Cardiac Rhythm Disease Management | 2014-10-21 |
| GEM 21S GROWTH FACTOR ENHANCE MATRIX (P040013/S019) | Lynch Biologics, LLC | 2014-10-21 |
| ATTAIN BIPOLAR OTW LEAD , ATTAIN OTW LEAD (P010015/S252) | Medtronic, Inc. | 2014-10-21 |
| CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S345) | ABBOTT MEDICAL | 2014-10-21 |
| SELECT SECURE LEAD (P030036/S075) | Medtronic Cardiac Rhythm Disease Management | 2014-10-21 |
| CAPSUREFIX NOVUS LEAD (P930039/S120) | Medtronic, Inc. | 2014-10-21 |
| DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D (P010012/S373) | Boston Scientific Corp | 2014-10-20 |
| SUPERA PERIPHERAL STENT SYSTEM (SUPERB) (P120020/S002) | Abbott Vascular (Idef Technologies Inc) | 2014-10-20 |
| MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM (P860004/S206) | Medtronic, Inc. | 2014-10-20 |
| DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S334) | Boston Scientific | 2014-10-20 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) (P130009/S012) | Edwards Lifesciences, LLC | 2014-10-20 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S044) | Medtronic Vascular | 2014-10-20 |
| SAPIEN TRANSCATHETER HEART VALVE (THV) (P110021/S045) | Edwards Lifesciences, LLC | 2014-10-20 |
| SAPIEN TRANSCATHETER HEART VALVE (THV) (P100041/S059) | Edwards Lifesciences, LLC | 2014-10-20 |
| COLLACOTE,COLLATAPE,COLLAPLUG ABSORABLE COLLAGEN WOUND DRESS (P840062/S040) | Integra Lifesciences Corp. | 2014-10-17 |
| HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S053) | Integra LifeSciences Corporation | 2014-10-17 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS-MICROFIBRILLAR FORM, COLLASTAT ABSORABLE COLAGEN HEMOSTATIC SPONGE (P810006/S053) | Integra LifeSciences Corporation | 2014-10-17 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S105) | W. L. Gore & Associates, Inc. | 2014-10-17 |
| R3 ACETABULAR SHELLS (P030022/S031) | Smith & Nephew, Inc. | 2014-10-17 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S059) | Boston Scientific | 2014-10-17 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S506) | Medtronic Cardiac Rhythm Disease Management | 2014-10-17 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S092) | Medtronic, Inc. | 2014-10-17 |
| BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI (P920047/S071) | Boston Scientific Corp | 2014-10-17 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S050) | Boston Scientific Corp | 2014-10-17 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S009) | Dexcom, Inc. | 2014-10-17 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S068) | W. L. Gore & Associates, Inc. | 2014-10-17 |
| SILSOFT (CLASTOFILCON A) CONTACT LENS (P850068/S012) | Bausch & Lomb, Inc. | 2014-10-17 |
| MEDTRONIC INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S068) | Medtronic Neuromodulation | 2014-10-17 |
| SYNCHROMED INFUSION SYSTEM (P860004/S215) | Medtronic, Inc. | 2014-10-17 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S071) | W. L. Gore & Associates, Inc. | 2014-10-17 |
| INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S035) | Integra Lifesciences Corp. | 2014-10-17 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S011) | W. L. Gore & Associates, Inc. | 2014-10-17 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S172) | Medtronic Neuromodulation | 2014-10-17 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D, EVERA S DR ICD (P010031/S470) | Medtronic Cardiac Rhythm Disease Management | 2014-10-17 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S209) | Medtronic, Inc. | 2014-10-17 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S038) | Integra Lifesciences Corp. | 2014-10-16 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S253) | Medtronic, Inc. | 2014-10-16 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S049) | Medtronic | 2014-10-16 |
| INTERSTIM THERAPY SYSTEM (P080025/S081) | Medtronic Neuromodulation | 2014-10-16 |
| GORE AAA ENDOPROSTHESIS (P020004/S104) | W. L. Gore & Associates, Inc. | 2014-10-16 |
| ARCHITECT CORE (LN 6L22) (P080023/S025) | Abbott Laboratories | 2014-10-16 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S208) | Medtronic, Inc. | 2014-10-16 |
| ARCHITECT ANTI-HCV (LN IL79) (P050042/S030) | Abbott Laboratories, Inc. | 2014-10-16 |
| CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S251) | Medtronic, Inc. | 2014-10-16 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S507) | Medtronic Cardiac Rhythm Disease Management | 2014-10-16 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORABABLE COLLAGEN WOUND GRESSING FOR DENTAL SURGERY (P840062/S042) | Integra Lifesciences Corp. | 2014-10-16 |
| RESTORE, ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEM, PISCES, SPECIFY AND VECTRIS, SPINAL CORD STIMULATION LEADS (P840001/S284) | Medtronic Neuromodulation | 2014-10-16 |
| 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 I (P980016/S505) | Medtronic Cardiac Rhythm Disease Management | 2014-10-16 |