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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH) (P980050/S063)Medtronic, Inc.2011-07-07
CAPSUREFIX MRI (P090013/S027)Medtronic, Inc.2011-07-07
PROTECTA DR/VR/XT DR/VR ICD (P980016/S303)Medtronic Cardiac Rhythm Disease Management2011-07-07
CAPSURE LEAD/ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/II ICDS (P980016/S304)Medtronic Cardiac Rhythm Disease Management2011-07-07
LIFEVEST WEARABLE BEFIBRILLATOR (P010030/S028)Zoll Manufacturing Corporation2011-07-07
CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+/CAPSURE (P930039/S057)Medtronic, Inc.2011-07-07
CAPSURE EPICARDIAL PACING LEAD (P950024/S032)Medtronic, Inc.2011-07-07
ACCULINK CAROTID STENT SYSTEM (P040012/S040)Abbott Vascular2011-07-07
VITATRON LEGACY IPG (P850051/S075)Medtronic, Inc.2011-07-07
CONCERTO/CONCERTO II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S258)Medtronic Cardiac Rhythm Disease Management2011-07-07
SELECTSECURE LEAD/SLEEVE KIT (P030036/S033)Medtronic Cardiac Rhythm Disease Management2011-07-07
CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT (P890003/S230)Medtronic, Inc.2011-07-07
PROTECTA/PROTECTA XT CRT-D (P010031/S257)Medtronic Cardiac Rhythm Disease Management2011-07-07
DISPOABLE COVER & EPG SAFETY CABLE (P820003/S107)Medtronic Cardiac Rhythm Disease Management2011-07-07
CAPSURE FIX LEAD & REVO MRI IPG (P090013/S029)Medtronic, Inc.2011-07-07
MEDTRONIC 350 SERIES IPG/ADAPTA/ADVISA/AT500/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA IPGS (P980035/S231)Medtronic, Inc.2011-07-07
INSYNC/ INSYNC III, CRT IPG'S (P010015/S128)Medtronic, Inc.2011-07-07
ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM (P050017/S006)Cook Ireland, Ltd.2011-07-05
COROX OTW UP STEROID-ELUTING LEAD (P050023/S014)Biotronik, Inc.2011-07-01
COROX OTW (-S) BP STEROID-ELUTING LEADS (P070008/S004)Biotronik, Inc.2011-07-01
KENTROX SL/SL-S/RV/RV-S & LINOX S/SD/T/TD STEROID-ELUTING LEADS (P980023/S034)Biotronik, Inc.2011-07-01
XIENCE V EVROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S074)Abbott Vascular, Inc.2011-07-01
SELOX SR/ST/JT, SETROX S, AND DEXTRUS STEROID-ELUTING LEADS (P950037/S062)Biotronik, Inc.2011-07-01
CARDIOSIGHT READER (P890003/S226)Medtronic, Inc.2011-07-01
SYNCRA/CONSULTA CRT-P (P010015/S125)Medtronic, Inc.2011-07-01
TRIFECTA VALVE (P100029/S005)ABBOTT MEDICAL2011-07-01
PARADYM CRT (P060027/S031)MicroPort CRM USA, Inc.2011-07-01
PARADYM VR/DR (P980049/S064)MicroPort CRM USA, Inc.2011-07-01
CONTAK RENEWAL TR (P030005/S078)Guidant Corp.2011-07-01
CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES (P900060/S042)Corcym S.r.l.2011-06-30
POWERLINK WITH INTUITRAK DELIVERY SYSTEM (P040002/S032)Endologix, LLC2011-06-30
CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES (P900060/S043)Corcym S.r.l.2011-06-30
VERIFLEX BARE-METAL CORONARY STENT SYSTEM (P040016/S072)Boston Scientific Scimed, Inc.2011-06-30
FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S044)Boston Scientific Corp2011-06-30
CARBOMEDICS/CARBO-SEAL ASCENDING & VALSALVA/ORBIS/OPTIFORM HEART VALVES (P900060/S044)Corcym S.r.l.2011-06-30
EXPRESS2 CORONARY STENT SYSTEM (P020009/S074)Boston Scientific Scimed, Inc.2011-06-30
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S071)Boston Scientific Corp2011-06-30
CAPSUREFIX MRI (P090013/S026)Medtronic, Inc.2011-06-29
ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW) (P100023/S004)Boston Scientific Corp2011-06-29
CAPSUREFIX & CRYSTALLINE ACT FIX (P930039/S055)Medtronic, Inc.2011-06-29
ACUITY STEERABLE STYLET ACCESSORY (P050046/S009)Guidant Corp.2011-06-29
QUICKFLEX U/UNIFY CRT-D (P030054/S191)ABBOTT MEDICAL2011-06-28
CURRENT ACCEL VR/DR ICD (P910023/S266)ABBOTT MEDICAL2011-06-28
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S010)Medtronic Cryocath, LP2011-06-28
PROMOTE ACCEL CRT-D (P030035/S084)ABBOTT MEDICAL2011-06-28
TENDRIL STS (P960013/S065)ABBOTT MEDICAL2011-06-28
CAPSURE EPI UNIPOLAR/BIPOLAR LEADS (P950024/S029)Medtronic, Inc.2011-06-27
CAPSURE Z/SP NOVUS LEADS/CAPSURE/VIATRON EXCELLENCE/SS+/VITATRON IMPULSE II CAPSURE SP Z LEADS (P850089/S075)Medtronic Cardiac Rhythm Disease Management2011-06-27
ATTAIN ABILITY LEAD (P080006/S021)Medtronic, Inc.2011-06-27
CAPSURE SP NOVUS/CAPSURE/CAPSURE SENSE LEADS/VITATRON EXCELLENCE PS+/VITATRON CRYSTALLINE (P830061/S062)Medtronic Cardiac Rhythm Disease Management2011-06-27
SELECTSECURE LEAD/SLEEVE KIT (P030036/S027)Medtronic Cardiac Rhythm Disease Management2011-06-27
MARQUIS/MAXIMO ICD/INTRINSIC ICD/CAPSURE LEAD/ENTRUST ICD/VIRTUOSO ICD/MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD (P980016/S288)Medtronic Cardiac Rhythm Disease Management2011-06-27
SIGMA IPG FAMILY/MEDTRONIC 350/ENRHYTHM/AT500 SYSTEMS/ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S211)Medtronic, Inc.2011-06-27
PRODIGY IPG/LEADS WRENCH KIT/LEADS SERVICE KIT/VITATRON BRILLIANT S+/CAPSURE VDD LEADS/CONNECTOR PORT PIN-PLUG (P890003/S219)Medtronic, Inc.2011-06-27
ATTAIN STARFIX LEAD (P060039/S024)Medtronic, Inc.2011-06-27
CAPSUREFIX NOVUS/SUREFIX/CAPSUREFIX/VITATRON PIROUET/VITATRON CRYSTALLINE ACTFIX LEADS (P930039/S050)Medtronic, Inc.2011-06-27
C & T SERIES IPG (P990001/S086)Medtronic, Inc.2011-06-27
REVO IPG & REVO MRI LEAD (P090013/S011)Medtronic, Inc.2011-06-27
PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S014)Medtronic Vascular, Inc.2011-06-27
CS-SVC TRANSVENE LEAD (P980050/S059)Medtronic, Inc.2011-06-27
INSYNC III CRT-P/ATTAIN OTW LEAD/BIPOLAR OTW/LV LEADS (P010015/S112)Medtronic, Inc.2011-06-27
INSYNC II/III MARQUIS/MARQUIS ICD/SENTRY ICD FAMILY/MAXIMO ICD FAMILY/CONCERTO CRT-D/MAXIMO II CRT-D/CONSULTA CRT-D (P010031/S242)Medtronic Cardiac Rhythm Disease Management2011-06-27
IS-1 PORT PIN PLUG/Y ADAPTOR KIT/LEAD ADAPTOR/SPRINT LEAD/QUATTRO/QUATTRO SECURE/SUBCUTANEOUS DEFIBRILLATION/TRANSVENE (P920015/S074)Medtronic, Inc.2011-06-27
ACE HEADER/PATCH LEAD/LEAD END PIN CAP (P900061/S100)Medtronic Cardiac Rhythm Disease Management2011-06-27
CONSULTA/SYNCRA CRT-PS (P010015/S127)Medtronic, Inc.2011-06-22
ADVISA IPG (P980035/S229)Medtronic, Inc.2011-06-22
LATITUDE PACEART INTEGRATION (P910077/S115)Boston Scientific2011-06-21
CADENCE/CURRENT/FORTIFY FAMILIES OF ICDS (P910023/S257)ABBOTT MEDICAL2011-06-21
EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS (P030054/S181)ABBOTT MEDICAL2011-06-21
CONTAK RENEWAL TR PG (P030005/S077)Guidant Corp.2011-06-17
ENDOTAK LEADS (P910077/S116)Boston Scientific2011-06-17
EASYTRAK LEADS/ACUITY LEADS/CONTAK RENEWAL PG/LIVIAN ICD/COGNIS ICD (P010012/S267)Boston Scientific Corp2011-06-17
CONFIENT PG/VENTAK PRIZM/VITALITY PG/TELIGEN PG (P960040/S244)Boston Scientific2011-06-17
TACHY ADAPTER (ACCESSORY) (P830060/S069)Boston Scientific2011-06-17
ACUITY LEADS (P050046/S011)Guidant Corp.2011-06-17
ENDOTAK/ ENDOTAK RELIANCE/ENDOTAK ENDURANCE LEADS (P910073/S098)Boston Scientific2011-06-17
FLEXTEND LEADS (P960006/S031)Boston Scientific2011-06-17
ATTAIN STARFIX (P060039/S023)Medtronic, Inc.2011-06-16
CAPSURE/Z NOVUS/VITATRON EXCELLENCE SS+/IMPULSE II (P850089/S074)Medtronic Cardiac Rhythm Disease Management2011-06-16
CAPSURE VDD2 LEAD / BRILLIANT ST LEAD (P890003/S218)Medtronic, Inc.2011-06-16
CAPSURE FIX MRI LEAD (P090013/S010)Medtronic, Inc.2011-06-16
CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+ (P930039/S049)Medtronic, Inc.2011-06-16
XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S058)Abbott Vascular, Inc.2011-06-16
ATTAIN LEAD (P010015/S111)Medtronic, Inc.2011-06-16
MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX ML-8 (P020047/S029)Abbott Vascular2011-06-16
CAPSURE/VITATRON CRYSTALINE & EXCELLENCE PS+ (P830061/S061)Medtronic Cardiac Rhythm Disease Management2011-06-16
RELIANCE IS-1 FAMILY OF LEADS (P910073/S089)Boston Scientific2011-06-14
CAPSURE SP Z LEADS/VITATRON IMPULSE/EXCELLENCE S+/SS+/IMPULSE II LEADS (P850089/S077)Medtronic Cardiac Rhythm Disease Management2011-06-10
EPICARDIAL LEADS AND ACCESSORIES (P900061/S103)Medtronic Cardiac Rhythm Disease Management2011-06-10
SYNCRA/CONSULTA CRT-P (P010015/S124)Medtronic, Inc.2011-06-10
VARIOUS FAMILIES OF ELECTROPHYSIOLOGY SYSTEMS (P930029/S030)Medtronic, Inc.2011-06-10
CAPSURE/VITATRON EXCELLENCE + (P830061/S065)Medtronic Cardiac Rhythm Disease Management2011-06-10
VITATRON PIROUET/S+/CRYSTALLINE ACTFIX/CAPSURE LEADS (P930039/S053)Medtronic, Inc.2011-06-10
PROTECTA/PROTECTA XT CRT-D (P010031/S256)Medtronic Cardiac Rhythm Disease Management2011-06-10
ADVISA DR IPG (P980035/S226)Medtronic, Inc.2011-06-10
IMPLANTABLE PULSE GENERATOR AND PROGRAMMER (P820003/S106)Medtronic Cardiac Rhythm Disease Management2011-06-10
KAPPA 400 IPG (P970012/S085)Medtronic, Inc.2011-06-10
CAPSURE (DRUG ELUTING) LEAD & PROGRAMMER ACCESSORY (P890003/S225)Medtronic, Inc.2011-06-10
TRANSVENE SVC LEAD (P920015/S077)Medtronic, Inc.2011-06-10
ATTAIN ABILITY PLUS/ATTAIN ABILITY STRAIGHT LEADS (P080006/S028)Medtronic, Inc.2011-06-10
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