| CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROT (P010031/S380) | Medtronic Cardiac Rhythm Disease Management | 2013-06-26 |
| INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD,SECUR (P980016/S420) | Medtronic Cardiac Rhythm Disease Management | 2013-06-26 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS UNISTEP PLUS DELIVERY SYSTEM (P980033/S033) | Boston Scientific Corporation | 2013-06-26 |
| ADVISA DR IPG,ENRHYTHM IPG,SIGMA DR AND SIGMA S IPG,ADVISA DR MRI IPG (P980035/S330) | Medtronic, Inc. | 2013-06-26 |
| VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG (P990001/S113) | Medtronic, Inc. | 2013-06-26 |
| CAROTID EALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S014) | Boston Scientific Corp | 2013-06-26 |
| WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S044) | Boston Scientific Corp | 2013-06-26 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S040) | Zoll Manufacturing Corporation | 2013-06-25 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, MITRAL BIOPROSTHESIS,; BIOPROSTHESIS VALVED CONDUIT; DURAFLEX LOW PRES (P870056/S059) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S030) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P100041/S029) | Edwards Lifesciences, LLC | 2013-06-25 |
| ENDURANT STENT GRAFT SYSTEM,ENDURANT II STENT GRAFT SYSTEM,ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM (P100021/S026) | Medtronic Vascular | 2013-06-25 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S043) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P110021/S015) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S016) | Edwards Lifesciences, LLC | 2013-06-25 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AORTIC BIOPROSTHESIS, RSR PERICARDIAL (P860057/S109) | Edwards Lifesciences, LLC | 2013-06-25 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS; BIOPROSTHESIS-EDWARDS DURAFLEX LOW PRESSURE MITRA (P870077/S054) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S041) | Edwards Lifesciences, LLC | 2013-06-25 |
| EVERA S DR ICD , D VR ICD, ST DR ICD, XT VR ICD; MAXIMO II ICD, PROTECTA ICD/ XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S421) | Medtronic Cardiac Rhythm Disease Management | 2013-06-24 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D/ XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S382) | Medtronic Cardiac Rhythm Disease Management | 2013-06-24 |
| FREEZOR, FREEZOR XTRA AND FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S048) | Medtronic Cryocath, LP | 2013-06-21 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S104) | Boston Scientific Scimed, Inc. | 2013-06-21 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S043) | Boston Scientific Corp | 2013-06-21 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S053) | Thoratec Laboratories Corp. | 2013-06-21 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S110) | Boston Scientific Scimed, Inc. | 2013-06-21 |
| ION PACILITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S072) | Boston Scientific Corp | 2013-06-21 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S053) | W. L. Gore & Associates, Inc. | 2013-06-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S082) | W. L. Gore & Associates, Inc. | 2013-06-21 |
| FLEXTOME CORONARY CUTTING BALLOON (P950020/S061) | Boston Scientific Corp | 2013-06-21 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, INCEEPTA, ENERGEN, PUNCTUA, TELIGEN , ICD'S (P960040/S295) | Boston Scientific | 2013-06-21 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S046) | Boston Scientific Corp | 2013-06-21 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS, INC EPTA, ENERGEN, PUNCTUA, C OGNIS CRT-D'S (P010012/S330) | Boston Scientific Corp | 2013-06-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S051) | Boston Scientific Corp | 2013-06-21 |
| LATITUDE COMMUNICATOR (P910077/S135) | Boston Scientific | 2013-06-20 |
| ARCTIC FRONT AND ARTIC FRONT ADVANCE (P100010/S024) | Medtronic Cryocath, LP | 2013-06-20 |
| REPLY/ESPRIT SR AND DR MODEL PACEMAKERS (P950029/S079) | MicroPort CRM USA, Inc. | 2013-06-20 |
| ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S134) | Boston Scientific | 2013-06-20 |
| CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S099) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S122) | Boston Scientific Corp | 2013-06-19 |
| EVERA S DR ICD,EVERA S VR, ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S419) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| ADAPTA, VERSA, SENSIA, RELIA IPG (P980035/S329) | Medtronic, Inc. | 2013-06-19 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S379) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S204) | Medtronic, Inc. | 2013-06-19 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD (P930039/S090) | Medtronic, Inc. | 2013-06-19 |
| LEAD ANCHORING SLEEVE KIT (P030036/S059) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| ATTAIN ABILITY LEAD (P080006/S055) | Medtronic, Inc. | 2013-06-19 |
| CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCLLENCE PS+ LEAD (P830061/S094) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| AORFIX AA FLEXIBLE STENT GRAFT SYSTEM (P110032/S003) | Lombard Medical Limited | 2013-06-18 |
| ADAPTA,VERSA,SENSIA IPG,RELIA IPG (P980035/S320) | Medtronic, Inc. | 2013-06-18 |
| WALLSTENT RP ENDOPROSTHESIS (ILIAC) (P940019/S035) | Boston Scientific Scimed, Inc. | 2013-06-18 |
| WALLSTENT RP ENDOPROSTHESIS AND WALLSTENT ENDOPROSTHESIS (VENOUS) (P980033/S029) | Boston Scientific Corporation | 2013-06-18 |
| WALLSTENT RP ENDOPROSTHESIS AND WALLSTENT ENDOPROTHESIS (TIPS) (P930031/S040) | Boston Scientific Corp | 2013-06-18 |
| AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM (P110032/S002) | Lombard Medical Limited | 2013-06-17 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S041) | Endologix, LLC | 2013-06-17 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S053) | W. L. Gore & Associates, Inc. | 2013-06-17 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S203) | Medtronic, Inc. | 2013-06-14 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S328) | Medtronic, Inc. | 2013-06-14 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D (P010031/S378) | Medtronic Cardiac Rhythm Disease Management | 2013-06-14 |
| SPECTRANETICS LASER SHEATH (P960042/S043) | Spectranetics (Philips) | 2013-06-14 |
| ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB (P100046/S002) | AtriCure, Inc. | 2013-06-14 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S052) | W. L. Gore & Associates, Inc. | 2013-06-14 |
| REVO MRT IPG (P090013/S100) | Medtronic, Inc. | 2013-06-14 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S418) | Medtronic Cardiac Rhythm Disease Management | 2013-06-14 |
| ARTIC FRONT CRYOABLATION CATHETER,ARTIC FRONT ADAVNCE CRYOABLATION CATHETER (P100010/S028) | Medtronic Cryocath, LP | 2013-06-12 |
| FORTIFY AND PROMOTE QUANDRA FAMILY OF ICDS (P910023/S316) | ABBOTT MEDICAL | 2013-06-12 |
| UNIFY AND UNIFY QUANDRA FAMILY OF CRT-DS (P030054/S248) | ABBOTT MEDICAL | 2013-06-12 |
| FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICDS (P910023/S318) | ABBOTT MEDICAL | 2013-06-12 |
| UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D'S (P030054/S250) | ABBOTT MEDICAL | 2013-06-12 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S051) | Edwards Lifesciences, LLC | 2013-06-11 |
| GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD (P900061/S121) | Medtronic Cardiac Rhythm Disease Management | 2013-06-11 |
| KAPPA 800, KAPPA 900, KAPPA 650, KAPPA 700, KAPPA800, KAPPA 900, RELIA, SENSIA, SIGMA, VERSA JEWEL AF GEM III AT (P980035/S321) | Medtronic, Inc. | 2013-06-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S019) | Edwards Lifesciences, LLC | 2013-06-11 |
| ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, VITATRON LEGACY, VITATRON LEGACY II (P890003/S273) | Medtronic, Inc. | 2013-06-11 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORNARY STENT SYSTEM (P070015/S110) | Abbott Vascular, Inc. | 2013-06-11 |
| LEGEND PLUS (P930022/S015) | Medtronic, Inc. | 2013-06-11 |
| PASYS,PASYS ST,SPECTRAX S,SPECTAX SX,SPECTRAX SX-HT,SPECTRAX SXT,SYMBIOS,SYMBIOS(AA),SYNERGYST (P820003/S120) | Medtronic Cardiac Rhythm Disease Management | 2013-06-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S100) | Edwards Lifesciences, LLC | 2013-06-11 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONORY STENT SYSTEM (P110019/S046) | Abbott Vascular | 2013-06-11 |
| KAPPA 400 (P970012/S093) | Medtronic, Inc. | 2013-06-11 |
| ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY (P850051/S080) | Medtronic, Inc. | 2013-06-11 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S056) | Edwards Lifesciences, LLC | 2013-06-11 |
| DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR (P980050/S082) | Medtronic, Inc. | 2013-06-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S040) | Edwards Lifesciences, LLC | 2013-06-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S005) | Edwards Lifesciences, LLC | 2013-06-11 |
| CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO-II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC II MARQUIS, INSY (P010031/S373) | Medtronic Cardiac Rhythm Disease Management | 2013-06-11 |
| ENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT (P980016/S413) | Medtronic Cardiac Rhythm Disease Management | 2013-06-11 |
| REVO MRI AND ENRHYTHM MRI (P090013/S093) | Medtronic, Inc. | 2013-06-11 |
| VITATRON (IPG'S) (P990001/S111) | Medtronic, Inc. | 2013-06-11 |
| CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILIES OF ICD DEVICES (P910023/S319) | ABBOTT MEDICAL | 2013-06-11 |
| CONSULTA CRT-P INSYNC, INSYNC III, SYNCRA CRT-P AND CONCERTO (P010015/S198) | Medtronic, Inc. | 2013-06-11 |
| PROMOTE+, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMI LIES OF CRT-D DEVICES (P030054/S251) | ABBOTT MEDICAL | 2013-06-11 |
| XACT CAROTID STENT SYSTEM (P040038/S029) | Abbott Vascular, Inc. | 2013-06-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S038) | Edwards Lifesciences, LLC | 2013-06-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S108) | Edwards Lifesciences, LLC | 2013-06-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM (P110021/S014) | Edwards Lifesciences, LLC | 2013-06-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM (P100041/S028) | Edwards Lifesciences, LLC | 2013-06-10 |
| OPEN PIVOT HEART VALVE (P990046/S032) | Medtronic Ats Medical, Inc. | 2013-06-07 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S108) | Abbott Vascular, Inc. | 2013-06-07 |
| ARCTIC FRONT AND ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS (P100010/S022) | Medtronic Cryocath, LP | 2013-06-07 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S084) | St. Jude Medical, Inc. | 2013-06-06 |