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Cardiovascular

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

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RecordFirmDate
MIRCO-DRIVER OVER-THE -WIRE(OTW) CORONARY STENT SYSTEM & MX2 CORONARY STENT SYSTEM (P030009/S005)Medtronic, Ireland2006-08-17
CONCERTO CRT-D (P010031/S046)Medtronic Cardiac Rhythm Disease Management2006-08-17
CONCERTO CRT-D (P010031/S047)Medtronic Cardiac Rhythm Disease Management2006-08-17
ENTRUST AND VIRTUOSO ICDS (P980016/S080)Medtronic Cardiac Rhythm Disease Management2006-08-17
ACCULINK & RX ACCULINK CAROTID STENT SYSTEM (P040012/S022)Abbott Vascular2006-08-17
ENTRUST AND VIRTUOSO ICDS (P980016/S078)Medtronic Cardiac Rhythm Disease Management2006-08-17
FRONTIER II BIVENTRICULAR PACING SYSTEMS (P030035/S018)ABBOTT MEDICAL2006-08-16
CONCERTO CRT-D (P010031/S045)Medtronic Cardiac Rhythm Disease Management2006-08-16
AFFINITY, INTEGRITY, AND IDENTITY PACEMAKERS (P880086/S125)ABBOTT MEDICAL2006-08-16
ENTRUST AND VIRTUOSO ICDS (P980016/S077)Medtronic Cardiac Rhythm Disease Management2006-08-15
NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER (P040036)Biosense Webster, Inc.2006-08-11
GORE HELEX SEPTAL OCCLUDER (P050006)W. L. Gore & Associates, Inc.2006-08-11
TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023)Biotronik, Inc.2006-08-10
EPIC HF SYSTEM (P030054/S033)ABBOTT MEDICAL2006-08-09
CADENCE TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S114)ABBOTT MEDICAL2006-08-09
VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S118)Boston Scientific2006-08-09
CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S121)Boston Scientific Corp2006-08-09
MICRONY SR + MODEL 2425T PULSE GENERATOR (P970013/S011)ABBOTT MEDICAL2006-08-09
FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM (P030035/S017)ABBOTT MEDICAL2006-08-09
SYNCHRONY MODEL 2020T PULSE GENERATOR (P880086/S124)ABBOTT MEDICAL2006-08-09
SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMER (P880006/S044)St. Jude Medical, Inc.2006-08-09
PARAGON, PHOENIX, MULTILOG & SENSORITHM PACEMAKERS (P830045/S101)St. Jude Medical, Inc.2006-08-09
LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 (P910077/S061)Boston Scientific2006-08-08
PRIZM AND VITALITY FAMILIES (P010012/S130)Boston Scientific Corp2006-08-08
CONTAK AND RENEWAL FAMILIES (P960040/S126)Boston Scientific2006-08-08
PERCLOSE A-T SUTURE MEDIATED CLOSURE(SMC) SYSTEM (P960043/S059)Abbott Vascular, Inc.2006-08-08
ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE (P040021/S001)ABBOTT MEDICAL2006-08-03
CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12 (P910001/S025)Spectranetics Corp.2006-08-02
CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12 (P960042/S009)Spectranetics (Philips)2006-08-02
CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE,PHOTON, EPIC, ATLAS,EPIC II AND ATLAS II AND ICD FAMILIES (P910023/S113)ABBOTT MEDICAL2006-07-31
EPIC HF, ATLAS + HF. EPIC II HF CRT- FAMILIES (P030054/S032)ABBOTT MEDICAL2006-07-31
SELECTED FAMILIES AND MODELS OF THE ICD'S (P910023/S102)ABBOTT MEDICAL2006-07-28
EPIC II/ EPIC II IMPLANTABLE CARDIOVERTERS (P030054/S023)ABBOTT MEDICAL2006-07-28
REGENCY,SENSOLOG AND DIALOG PACEMAKERS (P880006/S039)St. Jude Medical, Inc.2006-07-28
AURORA/QUANDRA,REFLEX,SIMPLEX AND META PACEMAKERS (P820018/S075)St. Jude Medical, Inc.2006-07-28
FRONTIER AND FRONTIER II CRT-P DEVICES (P030035/S009)ABBOTT MEDICAL2006-07-28
VARIOUS FAMILIES OF PACEMAKERS (P880086/S116)ABBOTT MEDICAL2006-07-28
DISCOVERY/MERIDIAN (P940031/S050)Boston Scientific2006-07-28
MICRONY PACEMAKERS (P970013/S006)ABBOTT MEDICAL2006-07-28
META AND TEMPO PACEMAKERS (P900070/S030)St. Jude Medical, Cardiac Rhythm Management Divisi2006-07-28
CONTAK CD/EASYTRAK (P010012/S110)Boston Scientific Corp2006-07-28
PRIZM/VITALITY (P960040/S110)Boston Scientific2006-07-28
PARAGON,PHOENIX,MULTILOG AND SENSORITHM PACEMAKERS (P830045/S096)St. Jude Medical, Inc.2006-07-28
CONTAK RENEWAL TR CRT-P SYSTEM (P030005/S037)Guidant Corp.2006-07-26
BIOGLUE SURGICAL ADHESIVE (P010003/S008)Cryolife, Inc.2006-07-26
INSYNC MARQUIS MODEL 7277, INSYNC II, MARQUIS MODEL 7289, INSYNC III MARQUIS MODEL 7279, INSYNC II PROTECT MODEL 7295 (P010031/S042)Medtronic Cardiac Rhythm Disease Management2006-07-26
NON-RATE RESPONSIVE PACEMAKERS (P900022/S007)MicroPort CRM USA, Inc.2006-07-26
VARIOUS MODELS OF PACEMAKERS ICS 3000/ EPR 1000 PLUS (P950037/S045)Biotronik, Inc.2006-07-26
VIGOR DR/SR PACEMAKER SYSTEM (P940031/S057)Boston Scientific2006-07-26
DELTA PACEMAKER SYSTEM (P840068/S044)Boston Scientific2006-07-26
VARIOUS MODELS OF ICD'S (P000009/S019)Biotronik, Inc.2006-07-26
MARQUIS DR/VR MODELS 7274, 7230B, 7230CX, 7230E (P980016/S075)Medtronic Cardiac Rhythm Disease Management2006-07-26
VARIOUS MODELS ICD'S TMS 1000 PLUS (P980023/S024)Biotronik, Inc.2006-07-26
VENTAK AV AICD SYSTEM (P960040/S130)Boston Scientific2006-07-26
RATE RESPONSIVE PACEMAKERS (P950029/S026)MicroPort CRM USA, Inc.2006-07-26
CONTAK CD/EASYTRAK CRT-D SYSTEM (P010012/S134)Boston Scientific Corp2006-07-26
MODEL 3120 ZOOM LATITUDE PROGRAMMER (P910077/S063)Boston Scientific2006-07-26
ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE FOR CHORUS MODELS 6001, 6003, 6004, 6033, AND 6034 (P980049/S023)MicroPort CRM USA, Inc.2006-07-26
CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S033)Corcym S.r.l.2006-07-21
THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S003)Irvine Biomedical,Inc.(Ibi)2006-07-20
VENTAK AV/VR (P960040/S129)Boston Scientific2006-07-19
TENDRIL FAMILY OF LEADS (P960013/S021)ABBOTT MEDICAL2006-07-19
S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM (P020036/S003)Cordis US Corporation2006-07-19
S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM (P020036/S004)Cordis US Corporation2006-07-19
AMPLATZER DUCT OCCLUDER (P020024/S011)ABBOTT MEDICAL2006-07-18
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S009)Abbott Vascular2006-07-18
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2800 & 2800TFX (P860057/S035)Edwards Lifesciences, LLC2006-07-18
XACT CAROTID STENT SYSTEM (P040038/S002)Abbott Vascular, Inc.2006-07-18
AMPLATZER SEPTAL OCCLUDER (P000039/S016)ABBOTT MEDICAL2006-07-18
CONTAK RENEWAL AND CONTAK RENEWAL 3 (P010012/S133)Boston Scientific Corp2006-07-17
MEDTRONIC ADAPTA,VERSA,&SENSIA IMPLANTABLE PULSE GENERATOR (P980035/S043)Medtronic, Inc.2006-07-17
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S017)Abbott Vascular2006-07-14
MULTI-LINK CORONARY STENT SYSTEMS (P970020/S047)Abbott Vascular, Inc.2006-07-13
MULTI-LINK VISION CORONARY STENT SYSTEMS (P020047/S006)Abbott Vascular2006-07-13
VIRTUOSO ICD (P980016/S076)Medtronic Cardiac Rhythm Disease Management2006-07-12
CONCERTO (P010031/S044)Medtronic Cardiac Rhythm Disease Management2006-07-12
ENTRUST ICD AND THE CARDIOSIGHT READER (P890003/S105)Medtronic, Inc.2006-07-12
MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S066)Medtronic Cardiac Rhythm Disease Management2006-07-12
STELIX II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D (P020030/S003)MicroPort CRM USA, Inc.2006-07-12
META PACEMAKER (P880038/S037)St. Jude Medical, Inc.2006-07-11
VARIOUS MODELS OF ICD'S (P910023/S111)ABBOTT MEDICAL2006-07-11
ANGIOJET XMI AND XMI-RX CATHETERS (P980037/S016)Boston Scientific Corp2006-07-11
LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S023)Biotronik, Inc.2006-07-11
CADENCE, MODEL V-100 (P910023/S112)ABBOTT MEDICAL2006-07-11
MICRONY PACEMAKER (P970013/S010)ABBOTT MEDICAL2006-07-11
PARAGON & PHOENIX PACEMAKERS (P830045/S100)St. Jude Medical, Inc.2006-07-11
EPIC/EPIC II HF & ATLAS + HF CRT-D'S (P030054/S030)ABBOTT MEDICAL2006-07-11
EPIC HF V-338 (P030054/S031)ABBOTT MEDICAL2006-07-11
META & TEMPO PACEMAKERS (P900070/S034)St. Jude Medical, Cardiac Rhythm Management Divisi2006-07-11
VARIOUS MODELS OF PACEMAKERS (P880086/S122)ABBOTT MEDICAL2006-07-11
REGENCY PACEMAKER (P880006/S043)St. Jude Medical, Inc.2006-07-11
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S016)Abbott Vascular2006-07-11
VARIOUS MODELS OF PACEMAKERS (P820018/S077)St. Jude Medical, Inc.2006-07-11
FRONTIER/FRONTIER II CRT-P (P030035/S016)ABBOTT MEDICAL2006-07-11
RIATA ST OPTIM LEADS MODELS 7020, 7021,7022,7030,7031,7070 AND 7071 (P950022/S030)ABBOTT MEDICAL2006-07-07
42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF (P900023/S044)Abiomed Cardiovascular, Inc.2006-07-07
FREEZOR CARDIAC CRYOABLATION CATHETERS; FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION CATHETERS (P020045/S015)Medtronic Cryocath, LP2006-07-05
XACT CAROTID STENT SYSTEM (P040038/S004)Abbott Vascular, Inc.2006-06-30
FLEXTOME & CUTTING BALLOON ULTRA (P950020/S017)Boston Scientific Corp2006-06-30
MEDTRONIC INSYNC MAXIMO AND INSYNC SENTRY DEVICES (P010031/S043)Medtronic Cardiac Rhythm Disease Management2006-06-30
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