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Cardiovascular

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

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RecordFirmDate
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S085)ABBOTT MEDICAL2008-04-29
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S162)ABBOTT MEDICAL2008-04-29
QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS (P860019/S223)Scimed Life Systems, Inc.2008-04-28
OVATIO DR & OVATIO VR ICDS (P980049/S034)MicroPort CRM USA, Inc.2008-04-25
QUICKSITE FAMILY OF LEADS-MODELS 1056K, 1056T AND 1058T & QUICKFLEX FAMILY OF LEADS-MODELS 1156T AND 1158T (P030054/S083)ABBOTT MEDICAL2008-04-23
ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S004)Spectranetics Corp.2008-04-23
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040)ABBOTT MEDICAL2008-04-21
ATTAIN LV & CS & OTW & ATTAIN BIPOLAR OTW (P010015/S042)Medtronic, Inc.2008-04-18
GEM DR ICD, GEM II & III FAMILIES, MARQUIS & MAXIMO FAMILES, ONYX, INTRINSIC & ENTRUST & VIRTUOSO FAMILIES OF ICDS (P980016/S125)Medtronic Cardiac Rhythm Disease Management2008-04-18
CAPSURE VDD-2 (P890003/S138)Medtronic, Inc.2008-04-18
CAPSURE FIX (P980016/S126)Medtronic Cardiac Rhythm Disease Management2008-04-18
INSYNC & INSYNC III (P010015/S041)Medtronic, Inc.2008-04-18
SELECTSECURE (P030036/S005)Medtronic Cardiac Rhythm Disease Management2008-04-18
CAPSUREFIX, CAPSUREFIX NOVUS, SUREFIX (P930039/S026)Medtronic, Inc.2008-04-18
GEM III (P980050/S032)Medtronic, Inc.2008-04-18
EXCELLENCE S+, CAPSURE Z, CAPSURE Z NOVUS, CAPSURE SP NOVUS, CAPSURE SP (P850089/S058)Medtronic Cardiac Rhythm Disease Management2008-04-18
KAPPA 600/700/650/800/900 FAMILIES (P980035/S090)Medtronic, Inc.2008-04-18
CAPSURE, CAPSURE SP, CAPSURE SP NOVUS, CAPSURE SENSE (P830061/S041)Medtronic Cardiac Rhythm Disease Management2008-04-18
INSYNC ICD & INSYNC MARQUIS, INSYNC II & III MARQUIS FAMILY & INSYNC II PROTECT & INSYNC SENTRY & MAXIMO FAMILY (P010031/S095)Medtronic Cardiac Rhythm Disease Management2008-04-18
THERA-I IPG (P890003/S137)Medtronic, Inc.2008-04-18
KAPPA 400 DR & SR (P970012/S034)Medtronic, Inc.2008-04-18
ENRHYTHM (P980035/S091)Medtronic, Inc.2008-04-18
DEMA FAMILIES & DIVA FAMILIES & SELECTION AFM & C-SERIES & T- SERIES (P990001/S037)Medtronic, Inc.2008-04-18
SPRINT & SPRINT QUATTRO & SPRINT QUATTRO SECURE (P920015/S041)Medtronic, Inc.2008-04-18
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S009)W. L. Gore & Associates, Inc.2008-04-18
VENTAK AV ICD (P960040/S164)Boston Scientific2008-04-17
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S010)Zoll Manufacturing Corporation2008-04-17
LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) MODELS H220, H225, H227, AND H229 (P010012/S176)Boston Scientific Corp2008-04-17
MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT SYSTEM (P990020/S031)Medtronic Vascular2008-04-15
THE TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027)Medtronic Vascular2008-04-15
FIRE STAR RX PTCA & DURA STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S094)Cordis Corp.2008-04-15
CORDIS PRECISE NITINOL STENT (P030047/S009)Cordis US Corporation2008-04-14
GORE VIATORR TIPS ENDOPROTHESIS (P040027/S007)W. L. Gore & Associates, Inc.2008-04-11
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S018)W. L. Gore & Associates, Inc.2008-04-11
CYLOS DR, PROTOS DR-CLS, PHILOS 2 DR, PHILOS DR, AXIOS DR (P950037/S058)Biotronik, Inc.2008-04-11
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S171)ABBOTT MEDICAL2008-04-11
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S028)W. L. Gore & Associates, Inc.2008-04-11
NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM (P050025/S008)Boston Scientific2008-04-09
CORDIS PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S013)Cordis US Corporation2008-04-09
FRONTIER AND FRONTIER II FAMILIES OF PACEMAKERS (P030035/S040)ABBOTT MEDICAL2008-04-04
IDENTITY, INTEGRITY, VERITY, VICTORY, AND ZEPHYR FAMILIES OF PACEMAKERS (P880086/S161)ABBOTT MEDICAL2008-04-04
ENRHYTHM IPG (P980035/S089)Medtronic, Inc.2008-04-04
PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S005)Medtronic Vascular, Inc.2008-04-04
CONTAK RENEWAL TR2 (P030005/S051)Guidant Corp.2008-04-03
CONCERTO (P010031/S093)Medtronic Cardiac Rhythm Disease Management2008-04-03
VIRTUOSO & ENTRUST (P980016/S123)Medtronic Cardiac Rhythm Disease Management2008-04-03
FINELINE II/THINLINE II (P960040/S163)Boston Scientific2008-04-02
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S012)W. L. Gore & Associates, Inc.2008-04-02
IMPLANTABLE PACEMAKER PULSE GENERATORS (P990001/S036)Medtronic, Inc.2008-04-02
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-SPIROFLEX VG THROMBECTOMY SET (P980037/S025)Boston Scientific Corp2008-03-28
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S011)W. L. Gore & Associates, Inc.2008-03-28
MYNX VASCULAR CLOSURE DEVICE (P040044/S006)Cordis US Corporation2008-03-27
ENRHYTHM IPG (P980035/S087)Medtronic, Inc.2008-03-26
INSYNC III CRT-P (P010015/S038)Medtronic, Inc.2008-03-26
PRIZM2/VITALITY (P960040/S162)Boston Scientific2008-03-26
CONTACT RENEWAL (P010012/S174)Boston Scientific Corp2008-03-26
CONFIENT TACHY PULSE GENERATORS (P960040/S161)Boston Scientific2008-03-21
POWERLINK SYSTEM (P040002/S015)Endologix, LLC2008-03-21
LIVIAN & RENEWAL RF HEART FAILURE PULSE GENERATORS (P010012/S173)Boston Scientific Corp2008-03-21
OVATIO VR & DR ICDS (P980049/S032)MicroPort CRM USA, Inc.2008-03-20
GORE VIABAHN ENDOPROSTHESIS (P040037/S011)W. L. Gore & Associates, Inc.2008-03-20
OVATIO VR & DR ICDS (P980049/S031)MicroPort CRM USA, Inc.2008-03-20
OVATIO VR & DR ICDS (P980049/S033)MicroPort CRM USA, Inc.2008-03-20
OVATIO VR & DR ICDS (P980049/S030)MicroPort CRM USA, Inc.2008-03-20
FLEXTOME CUTTING BALLOON MONORAIL (MR), FLEXTOME CUTTING BALOON OTW, CUTTING BALLOON ULTRA2 MR/OTW (P950020/S026)Boston Scientific Corp2008-03-20
CONTAK RENEWAL TR/TR2 FAMILY OF PACEMAKERS (P030005/S050)Guidant Corp.2008-03-18
ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE (P930038/S054)Terumo Medical Corporation2008-03-18
SMARTVIEW (P980049/S035)MicroPort CRM USA, Inc.2008-03-18
ISOFLEX OPTIM LEADS (P960030/S020)ABBOTT MEDICAL2008-03-18
SMARTVIEW (P950029/S034)MicroPort CRM USA, Inc.2008-03-18
SMARTVIEW (P900022/S010)MicroPort CRM USA, Inc.2008-03-18
CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S084)Medtronic Cardiac Rhythm Disease Management2008-03-17
EPIC HF CRT-D'S (P030054/S063)ABBOTT MEDICAL2008-03-17
CADENCE ICD'S (P910023/S150)ABBOTT MEDICAL2008-03-17
LATITUDE PACEART INTEGRATION SYSTEM (P910077/S084)Boston Scientific2008-03-17
CONTAK RENEWAL 3 AVT CRT-D (P010012/S175)Boston Scientific Corp2008-03-17
SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR (P980016/S114)Medtronic Cardiac Rhythm Disease Management2008-03-17
MEDTRONIC 2490C CARELINK MONITOR 2020A CARDIOSIGHT READER (P890003/S131)Medtronic, Inc.2008-03-17
GORE VIABAHN ENDOPROSTHESIS (P040037/S010)W. L. Gore & Associates, Inc.2008-03-14
CONTAK RENEWAL 3 AVT CRT-D SYSTEM (P010012/S037)Boston Scientific Corp2008-03-13
CRYOCOR CRYOABLATION SYSTEM (P050024/S001)Boston Scientific Corp2008-03-13
SCORPION & SCORPION M ABLATION CATHETERS (P000020/S011)Boston Scientific Corp2008-03-13
FLAIR ENDOVASCULAR STENT GRAFT (P060002/S001)Bard Peripheral Vascular2008-03-13
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S022)W. L. Gore & Associates, Inc.2008-03-13
LEXOS AND LUMOS ICDS & XELOS DR-T ICD (P000009/S024)Biotronik, Inc.2008-03-11
LUMAX ICDS & CRT-DS (P050023/S008)Biotronik, Inc.2008-03-11
CADENCE FAMILY OF ICDS (P910023/S169)ABBOTT MEDICAL2008-03-11
EPIC HF FAMILY OF CRT-DS (P030054/S082)ABBOTT MEDICAL2008-03-11
LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S (P000009/S025)Biotronik, Inc.2008-03-10
LUMAX VR/DR/HF (-T) ICD'S & CRT-D'S (P050023/S009)Biotronik, Inc.2008-03-10
EPIC HF CRT-DS (P030054/S080)ABBOTT MEDICAL2008-03-06
MEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID SYSTEM (P070012/S001)Medtronic Vascular2008-03-06
EPIC HF/ATLAS HF FAMILY OF CRT-D'S (P030054/S081)ABBOTT MEDICAL2008-03-06
CADENCE FAMILY OF ICDS (P910023/S168)ABBOTT MEDICAL2008-03-06
CADENCE ICDS (P910023/S167)ABBOTT MEDICAL2008-03-06
AMPLATZER SEPTAL OCCLUDER & AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER-CRIBRIFORM (P000039/S025)ABBOTT MEDICAL2008-03-05
ACUITY STEERABLE LEAD (P050046/S002)Guidant Corp.2008-03-05
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER (P040002/S014)Endologix, LLC2008-03-05
AMPLATZER DUCT OCCLUDER (P020024/S019)ABBOTT MEDICAL2008-03-05
AMPLATZER MUSCULSR VSD OCCLUDER (P040040/S004)ABBOTT MEDICAL2008-03-05
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