| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S061) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S026) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S038) | Edwards Lifesciences, LLC | 2013-09-20 |
| CARPENTIER EDWARDS PERIMOUNT PERICARDIAL AOTRIC BIOPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS, RSRTHEON (P860057/S111) | Edwards Lifesciences, LLC | 2013-09-20 |
| EDWARDS SAPIEN TRANSCATHER HEART VALVE (P110021/S025) | Edwards Lifesciences, LLC | 2013-09-20 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S213) | Medtronic, Inc. | 2013-09-19 |
| PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S303) | Boston Scientific | 2013-09-19 |
| MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM (P110040) | Medtronic Vascular | 2013-09-19 |
| PUNCTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S339) | Boston Scientific Corp | 2013-09-19 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S080) | Medtronic, Inc. | 2013-09-18 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S067) | Medtronic, Ireland | 2013-09-18 |
| RESOLUTE INTEGRITY CORONARY STENT SYSTEM (P110013/S025) | Medtronic Vascular | 2013-09-18 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S004) | Medtronic, Ireland | 2013-09-18 |
| ENTOTAK LEAD SYSTEM (P910073/S120) | Boston Scientific | 2013-09-17 |
| EASYTRAK AND ACUITY SPIRAL LEAD SYSTEM (P010012/S338) | Boston Scientific Corp | 2013-09-17 |
| PROMUS ELEMENT PLUS STENT SYSTEM (P110010/S059) | Boston Scientific Corp | 2013-09-17 |
| BARD E-LUMINEXX VASCULAR STENT SYSTEM (P080007/S018) | Bard Peripheral Vascular, Inc. | 2013-09-17 |
| ACUITY STEERABLE LEAD SYSTEM (P050046/S020) | Guidant Corp. | 2013-09-17 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S033) | Bard Peripheral Vascular | 2013-09-16 |
| ATTAIN BIPOLAR OTW LEAD (P010015/S209) | Medtronic, Inc. | 2013-09-16 |
| XIENCE XPEDITION EVEROLIMUS CORONARY STENT SYSTEM (P110019/S052) | Abbott Vascular | 2013-09-13 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S023) | Edwards Lifesciences, LLC | 2013-09-13 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S010) | Abbott Vascular, Inc. | 2013-09-13 |
| REVO MRI IPG (P090013/S111) | Medtronic, Inc. | 2013-09-12 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S028) | Medtronic Vascular | 2013-09-12 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S016) | Medtronic Vascular | 2013-09-12 |
| CONSULTA CRT-P , SYNCRA CRT-P (P010015/S214) | Medtronic, Inc. | 2013-09-12 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S342) | Medtronic, Inc. | 2013-09-12 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S051) | W. L. Gore & Associates, Inc. | 2013-09-10 |
| SPRINT QUATTRO LEAD, SPLITTER/ADAPTOR, DF-4 IMPLANT TOOL KIT FOR MDT LEADS (P920015/S108) | Medtronic, Inc. | 2013-09-10 |
| FINELINE II STEROX LEAD (P960004/S060) | Boston Scientific | 2013-09-09 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S017) | Cryolife, Inc. | 2013-09-06 |
| ROTABLATOR ROTALLIN ADVANCER AND CATHETER (P900056/S125) | Boston Scientific Corp | 2013-09-06 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S029) | Medtronic | 2013-09-06 |
| ANTHEM RF CRT-PS (P030035/S112) | ABBOTT MEDICAL | 2013-09-05 |
| NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES (P990025/S038) | Biosense Webster, Inc. | 2013-09-05 |
| CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,,EZ STEER DS CATHETER (P950005/S045) | Biosense Webster, Inc. | 2013-09-05 |
| BIOSENSE WEBSTER CABLES (P990071/S024) | Biosense Webster, Inc. | 2013-09-05 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY SYSTEM (RX AND OTW) (P110013/S020) | Medtronic Vascular | 2013-09-05 |
| NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHE (P040036/S039) | Biosense Webster, Inc. | 2013-09-05 |
| CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER, (P010068/S035) | Biosense Webster, Inc. | 2013-09-05 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S107) | Boston Scientific Scimed, Inc. | 2013-09-05 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S113) | Boston Scientific Scimed, Inc. | 2013-09-05 |
| CELCIUS THERMOCOOL CATHETER,CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETE (P030031/S055) | Biosense Webster, Inc. | 2013-09-05 |
| ACCENT DR RF,ACCENT SR RF PACEMAKER DEVICES (P880086/S234) | ABBOTT MEDICAL | 2013-09-05 |
| CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER (P890003/S260) | Medtronic, Inc. | 2013-09-05 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S039) | Boston Scientific Corp | 2013-09-04 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S432) | Medtronic Cardiac Rhythm Disease Management | 2013-09-03 |
| BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S393) | Medtronic Cardiac Rhythm Disease Management | 2013-09-03 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S021) | Medtronic | 2013-08-30 |
| HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S023) | Medtronic | 2013-08-30 |
| REPLY SR, REPLY DR, ESPRIT DR (P950029/S082) | MicroPort CRM USA, Inc. | 2013-08-30 |
| PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S082) | Abbott Vascular, Inc. | 2013-08-29 |
| INTEGRITY OVER-THE-WIRE CORONARY STENT SYSTEMS (P030009/S066) | Medtronic, Ireland | 2013-08-29 |
| SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC (P110016/S007) | ABBOTT MEDICAL | 2013-08-29 |
| RESOLUTE INTEGRITY OVER-THE-WIRE ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S023) | Medtronic Vascular | 2013-08-29 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S009) | Boston Scientific Corporation | 2013-08-28 |
| ICD DEVICES (P910023/S320) | ABBOTT MEDICAL | 2013-08-28 |
| CRT- D DEVICES (P030054/S252) | ABBOTT MEDICAL | 2013-08-28 |
| CHILLI II COOL ABLATION CATHETER (P980003/S038) | Boston Scientific Corp | 2013-08-28 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S022) | Medtronic Vascular | 2013-08-28 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S113) | Abbott Vascular, Inc. | 2013-08-27 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORNARY STENT SYSTEM (P110019/S051) | Abbott Vascular | 2013-08-27 |
| TRIVASCULAR, INC. OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S004) | Endologix, LLC | 2013-08-27 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S009) | Abbott Vascular, Inc. | 2013-08-27 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S052) | Abbott Vascular | 2013-08-27 |
| AFX ENDOVASCULAR AAA DELIVERY SYSTEM (P040002/S042) | Endologix, LLC | 2013-08-26 |
| GORE EXCLUDER AAA ENDOPROSATHESIS WITH C3 DELIVERY SYSTEM (P020004/S085) | W. L. Gore & Associates, Inc. | 2013-08-26 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S211) | Medtronic, Inc. | 2013-08-22 |
| ADAPTA, VERSA, SENSIA IPG; ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S340) | Medtronic, Inc. | 2013-08-22 |
| EZ STEER THERMOCOOL NAV (P040036/S038) | Biosense Webster, Inc. | 2013-08-22 |
| INTUA (P030005/S101) | Guidant Corp. | 2013-08-22 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S011) | Medtronic Vascular | 2013-08-22 |
| BRAVA CRT-D, CONCERTO II CRT-D, COSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D (P010031/S391) | Medtronic Cardiac Rhythm Disease Management | 2013-08-22 |
| VITATRON C20 SR IPG; C60 DR IPG; T20 SR IPG; T60 DR IPG (P990001/S115) | Medtronic, Inc. | 2013-08-22 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S013) | Boston Scientific Corporation | 2013-08-22 |
| REVO MRI IPG (P090013/S109) | Medtronic, Inc. | 2013-08-22 |
| LIVEWIRE TC ABLATION CATHETER (P960016/S041) | St Jude Medical | 2013-08-22 |
| ZILVER VASCULAR STENT (P050017/S008) | Cook Ireland, Ltd. | 2013-08-22 |
| EVERA S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; INTRINSIC ICD; MARQUIS DR ICD, VR ICD; MAXIMO DR ICD, MAXIMO II ICD, MAX (P980016/S430) | Medtronic Cardiac Rhythm Disease Management | 2013-08-22 |
| PRODIGY IPG (P890003/S282) | Medtronic, Inc. | 2013-08-22 |
| EXPRESS LD ILLIAC PEMOUNTED STENT SYSTEM (P090003/S026) | Boston Scientific Corporation | 2013-08-22 |
| Y ADAPTOR/EXTENDER KIT, HV SPLITTER/ ADAPTOR KIT (P920015/S114) | Medtronic, Inc. | 2013-08-22 |
| VITALIO, FORMIO (N970003/S154) | Boston Scientific Corp | 2013-08-22 |
| BRAVA,VIVA S,VIVA XT CRT-DS (P010031/S390) | Medtronic Cardiac Rhythm Disease Management | 2013-08-22 |
| NAVISTAR THERMOCOOL (P030031/S054) | Biosense Webster, Inc. | 2013-08-22 |
| ATTAIN ABILITY LEADS (P080006/S056) | Medtronic, Inc. | 2013-08-22 |
| EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS (P980016/S429) | Medtronic Cardiac Rhythm Disease Management | 2013-08-22 |
| CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS (P910001/S066) | Spectranetics Corp. | 2013-08-21 |
| ZOOM LATITUDE PROGRAMMER (P910077/S136) | Boston Scientific | 2013-08-21 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S019) | Spectranetics Corp. | 2013-08-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S057) | Boston Scientific Corp | 2013-08-21 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR SYSTEM (S-ICD) (P110042/S012) | Boston Scientific Corporation | 2013-08-20 |
| MYNX ACE VASCULAR CLOSURE DEVICE (6F/7F) (P040044/S047) | Cordis US Corporation | 2013-08-19 |
| REGENT MECHANICAL HEART VALVE (P810002/S084) | ABBOTT MEDICAL | 2013-08-19 |
| AMPLATZER DUCT OCCLUDER II (P020024/S037) | ABBOTT MEDICAL | 2013-08-18 |
| NIT-OCCLUD PDA (P120009) | Pfm Medical, Inc. | 2013-08-16 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS (P860057/S110) | Edwards Lifesciences, LLC | 2013-08-16 |
| EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S018) | Boston Scientific Corp | 2013-08-15 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S427) | Medtronic Cardiac Rhythm Disease Management | 2013-08-14 |