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Cardiovascular

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

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RecordFirmDate
EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S163)ABBOTT MEDICAL2010-08-13
RF MARINR/RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II/ RF CONTACTR (P930029/S025)Medtronic, Inc.2010-08-13
CAPSURE EPI UNIPOLAR/BIPOLAR LEADS (P950024/S023)Medtronic, Inc.2010-08-13
EXPRESS2 CORONARY STENT SYSTEMS (MONORAIL & OVER-THE-WIRE) (P020009/S056)Boston Scientific Scimed, Inc.2010-08-13
IMPLANTABLE PULSE GENERATOR PACEMAKER (P940031/S068)Boston Scientific2010-08-13
ATS OPEN PIVOT HEART VALVE & ATS OPEN PIVOT AORTIC VALVED GRAFT (P990046/S022)Medtronic Ats Medical, Inc.2010-08-13
CS-SVC TRANSVENE LEAD (P980050/S051)Medtronic, Inc.2010-08-13
TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT (P920015/S064)Medtronic, Inc.2010-08-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (MONORAIL & OVER-THE-WIRE) (P030025/S078)Boston Scientific Corp2010-08-13
ATTAIN STARFIX (P060039/S015)Medtronic, Inc.2010-08-13
ROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER (P900056/S099)Boston Scientific Corp2010-08-13
INSYNC SENTRY & INSYNC MAXIMO (P010031/S209)Medtronic Cardiac Rhythm Disease Management2010-08-13
VENTAK AV/VENTAK PRIZM DR/VR/VITALITY/CONFIENT/TELIGEN (P960040/S226)Boston Scientific2010-08-13
LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S031)St Jude Medical2010-08-13
CAPSURE SENSE/SP NOVUS LEADS/VITATRON CRYSTALLINE/EXCELLENCE+/PS+ (P830061/S054)Medtronic Cardiac Rhythm Disease Management2010-08-13
PTCA CATHETERS (P860019/S259)Scimed Life Systems, Inc.2010-08-13
350 SERIES/ADAPTOR/AT500/ENPULSE/ENRHYTHM/KAPPA 600/650/700/800/900/RELIA/SENSIA/VERSA/SIGMA/PATIENT ACTIVATOR (P980035/S180)Medtronic, Inc.2010-08-13
LEAD & Y ADAPTOR/TUNNELING TOOL/TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT (P920015/S063)Medtronic, Inc.2010-08-13
BSC CRV ENDOTAK LEADS (P910073/S085)Boston Scientific2010-08-13
KAPPA 400 (P970012/S072)Medtronic, Inc.2010-08-13
CAPSURE SP/SP NOVUS LEADS/CAPSURE SENSE/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS +/+ (P830061/S053)Medtronic Cardiac Rhythm Disease Management2010-08-13
SELECTSECURE & ANCHORING SLEEVE KIT (P030036/S021)Medtronic Cardiac Rhythm Disease Management2010-08-13
CAPSURE SENSE/SP NOVUS/VITATRON CRYSTALINE/EXCELLENCE PS+ (P830061/S055)Medtronic Cardiac Rhythm Disease Management2010-08-13
ANCHORING SLEEVE KIT (P030036/S020)Medtronic Cardiac Rhythm Disease Management2010-08-13
JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD/INCHECK PATIENT ASSISTANT (P980050/S053)Medtronic, Inc.2010-08-13
VENTAK PRX & VENTAK MINI I-IV (P910077/S106)Boston Scientific2010-08-13
ADAPTA/VERSA/SENSIA/RELIA (P980035/S181)Medtronic, Inc.2010-08-13
CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II (P980016/S254)Medtronic Cardiac Rhythm Disease Management2010-08-13
CAPSURE SPZ/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/VITATRON IMPULSE/IMPULSE II (P850089/S067)Medtronic Cardiac Rhythm Disease Management2010-08-13
ATTAIN LV/CS LEADS (P010015/S095)Medtronic, Inc.2010-08-13
CAPSURE FIX NOVUS/SUREFIX LEADS/CAPSURE FIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET+/VITATRON PIROUET S+ (P930039/S040)Medtronic, Inc.2010-08-13
CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/II MARQUIS/MAXIMO II/II PROTECT/III MARQUIS/SENTRY/CONEXUS ACTIVATOR (P010031/S210)Medtronic Cardiac Rhythm Disease Management2010-08-13
ATTAIN (P080006/S013)Medtronic, Inc.2010-08-13
EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S164)ABBOTT MEDICAL2010-08-13
CAPSURE EPICARDIAL PACING LEAD (P950024/S024)Medtronic, Inc.2010-08-13
ATTAIN ABILITY (P080006/S012)Medtronic, Inc.2010-08-13
CAPSURE SP Z/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE SS+/IMPULSE II (P850089/S069)Medtronic Cardiac Rhythm Disease Management2010-08-13
DISPOSABLE COVER/EXTERNAL PULSE GENERATORS/CABLES/ADAPTOR/SURGICAL CABLE/PATIENT SAFETY CABLES/DISPOSABLE POUCH/SEM (P820003/S097)Medtronic Cardiac Rhythm Disease Management2010-08-13
CAPSURE FIX NOVUS LEADS/SUREFIX LEAD/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+ (P930039/S041)Medtronic, Inc.2010-08-13
ACE HEADER/TRANSVENE DEFIBRILLATION LEAD/LEAD END PIN CAP/UPSIZING SLEEVE (P900061/S092)Medtronic Cardiac Rhythm Disease Management2010-08-13
ATTAIN LV/CS/OTW LEADS (P010015/S094)Medtronic, Inc.2010-08-13
CONTAK RENEWAL TR (P030005/S065)Guidant Corp.2010-08-13
RF MARINR/NTC/5RF MARINR/RF CONDUCTR/RF ENHANCR II/RF CONTACTR (P930029/S024)Medtronic, Inc.2010-08-13
CAPSURE EPI UNIPOLAR/BIPOLAR LEADS (P950024/S022)Medtronic, Inc.2010-08-13
CAPSURE Z/SP NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II (P850089/S068)Medtronic Cardiac Rhythm Disease Management2010-08-13
BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S013)Bard Peripheral Vascular2010-08-13
ATTAIN STARFIX (P060039/S014)Medtronic, Inc.2010-08-13
KAPPA 400 DR/SR/ REMOTE ASSISTANT (P970012/S073)Medtronic, Inc.2010-08-13
CADENCE/CURRENT FAMILY OF ICDS (P910023/S244)ABBOTT MEDICAL2010-08-13
XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S041)Abbott Vascular, Inc.2010-08-13
CAPSURE/BRILLIANT S+ VDD LEADS/PRODIGY SR/WRENCH KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA/PACING SYSTEM ANALYZER (P890003/S198)Medtronic, Inc.2010-08-13
IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/QUATTRO SECURE/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE SVC LEAD (P920015/S065)Medtronic, Inc.2010-08-13
ANCHORING SLEEVE KIT & SELECTSECURE (P030036/S019)Medtronic Cardiac Rhythm Disease Management2010-08-13
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S035)W. L. Gore & Associates, Inc.2010-08-06
EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S160)ABBOTT MEDICAL2010-08-06
FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CCT.2 CRYOCONSOLE (P020045/S028)Medtronic Cryocath, LP2010-08-06
GORE HELEX SEPTAL OCCLUDER (P050006/S017)W. L. Gore & Associates, Inc.2010-08-06
COGNIS PULSE GENERATORS (P010012/S245)Boston Scientific Corp2010-08-06
CADENCE/CURRENT FAMILY OF ICDS (P910023/S241)ABBOTT MEDICAL2010-08-06
GORE VIABAHN ENDOPROSTHESIS (P040037/S027)W. L. Gore & Associates, Inc.2010-08-06
EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S161)ABBOTT MEDICAL2010-08-06
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S080)Cordis Corp.2010-08-06
TELIGEN PULSE GENERATORS (P960040/S225)Boston Scientific2010-08-06
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S054)W. L. Gore & Associates, Inc.2010-08-06
CADENCE/CURRENT FAMILY OF ICDS (P910023/S242)ABBOTT MEDICAL2010-08-06
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S020)W. L. Gore & Associates, Inc.2010-08-06
ATTAIN ABILITY LEAD (P080006/S011)Medtronic, Inc.2010-08-05
QUICKFLEX OF LEFT HEART LEADS (P030054/S158)ABBOTT MEDICAL2010-08-05
SPRINT QUATTRO (P920015/S062)Medtronic, Inc.2010-08-05
LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S034)Biotronik, Inc.2010-08-04
ADAPTA/RELIA/SENSIA/VERSA (P980035/S162)Medtronic, Inc.2010-08-04
INSYNC 3 CRT-P (P010015/S092)Medtronic, Inc.2010-08-02
ENRHYTHM IPG (P980035/S173)Medtronic, Inc.2010-08-02
VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD (P050023/S032)Biotronik, Inc.2010-07-30
STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS (P070008/S016)Biotronik, Inc.2010-07-30
EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX (P950037/S082)Biotronik, Inc.2010-07-30
KAINOX VCS, LINOX S/T/SD/TD, KENTROX SL-S/RV-S/SL/RV STEROID, LINOX(SMART) ST/TD LEADS (P980023/S041)Biotronik, Inc.2010-07-30
LEXOS DR/DR-T/VR/VR-T AND LUMOS DR-T/VR-T ICDS (P000009/S039)Biotronik, Inc.2010-07-30
CONCERTO/CONSULTA & MAXIMO II CRT-DS (P010031/S207)Medtronic Cardiac Rhythm Disease Management2010-07-28
BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S004)Boston Scientific Corp2010-07-28
POWERLINK SYSTEM FOR AAA (P040002/S026)Endologix, LLC2010-07-28
HANCOCK II PORCINE BIOPROSTHESIS MODELS T505 & T510 (P980043/S027)Medtronic, Inc.2010-07-28
HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S026)Medtronic Heart Valves2010-07-28
BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS (P860019/S258)Scimed Life Systems, Inc.2010-07-28
HANCOCK LOW POROSITY VALVED CONDUIT MODEL 105 (P870078/S010)Medtronic, Inc.2010-07-28
ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S178)Medtronic, Inc.2010-07-28
DA+C & DA+T SERIES (P990001/S071)Medtronic, Inc.2010-07-28
ENRHYTHM/RELIA/ADAPTA/VERSA/SENSIA IPGS (P980035/S176)Medtronic, Inc.2010-07-28
SECURA DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS (P980016/S251)Medtronic Cardiac Rhythm Disease Management2010-07-28
MAXIMO II/SECURA/VIRTUOSO/VIRTUOSO II (P980016/S249)Medtronic Cardiac Rhythm Disease Management2010-07-23
KAPPA 600/700/650/800/900/RELIA/ENPULSE/ADAPTA/VERSA/SENSIA IPGS (P980035/S175)Medtronic, Inc.2010-07-23
TRANSVENE DEFRIBRILLAITON LEAD (P900061/S090)Medtronic Cardiac Rhythm Disease Management2010-07-23
CONCERTO/CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S205)Medtronic Cardiac Rhythm Disease Management2010-07-23
CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S204)Medtronic Cardiac Rhythm Disease Management2010-07-23
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S039)Abbott Vascular, Inc.2010-07-23
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S248)Medtronic Cardiac Rhythm Disease Management2010-07-23
KAPPA 400 SR IPG (P970012/S070)Medtronic, Inc.2010-07-23
TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S037)Boston Scientific Corp2010-07-22
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910077/S105)Boston Scientific2010-07-22
TAXUS LIBERTE LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S038)Boston Scientific Corp2010-07-22
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Every clearance here is in the API, with alerts when new ones post.