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Cardiovascular

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

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RecordFirmDate
BLAZER II XP, BLAZER XP RPM CARDIAC ABLATION CATHETERS (P020025/S013)Boston Scientific2005-10-06
ENTRUST ICD (P980016/S052)Medtronic Cardiac Rhythm Disease Management2005-09-30
ENRHYTHM IPG (P980035/S045)Medtronic, Inc.2005-09-30
CARELINK PROGRAMMER (MODEL 2090)/ANALYZER (MODEL 2290) (P890003/S086)Medtronic, Inc.2005-09-28
EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S011)W. L. Gore & Associates, Inc.2005-09-28
CONTAK RENEWAL TR (P030005/S018)Guidant Corp.2005-09-27
DISCOVERY/MERIDIAN (P940031/S043)Boston Scientific2005-09-27
ROTAWIRE GUIDE WIRE, A COMPONENT OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S083)Boston Scientific Corp2005-09-27
CONTAK RENEWAL (P010012/S073)Boston Scientific Corp2005-09-27
PRIZM/VITALITY (P960040/S085)Boston Scientific2005-09-27
CONTAK RENEWAL (P010012/S072)Boston Scientific Corp2005-09-23
ENDOTAK RELIANCE LEADS (P910073/S054)Boston Scientific2005-09-23
VITALITY (P960040/S082)Boston Scientific2005-09-23
MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S021)Medtronic Vascular2005-09-22
VITAITY HE MODELS T180 & T182, AND VENTAK PRIZM 2 VR MODEL 1860 AICDS (P960040/S072)Boston Scientific2005-09-22
VITATRON T-SERIES SOFTWARE MODEL VSF07/08, VSE03/04 (P990001/S019)Medtronic, Inc.2005-09-21
MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM (P010031/S025)Medtronic Cardiac Rhythm Disease Management2005-09-21
CONTAK RENEWAL 3&4 FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES (P010012/S061)Boston Scientific Corp2005-09-21
MEDTRONIC PACEMAKER SYSTEMS (P890003/S088)Medtronic, Inc.2005-09-21
MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P980016/S054)Medtronic Cardiac Rhythm Disease Management2005-09-21
VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S069)Boston Scientific2005-09-21
AMPLATZER DUCT OCCLUDER (P000039/S007)ABBOTT MEDICAL2005-09-16
AMPLATZER DUCT OCCLUDER (P020024/S002)ABBOTT MEDICAL2005-09-16
MEDTRONIC ENPULSE E1/E2 IMPLANTABLE PULSE GENERATOR DEVICES (P980035/S046)Medtronic, Inc.2005-09-15
VENTALITY FAMILIES (P960040/S079)Boston Scientific2005-09-15
CONTAK RENEWAL 3 (P010012/S070)Boston Scientific Corp2005-09-15
PRIZM 2 (P960040/S080)Boston Scientific2005-09-15
RENEWAL DS (P010012/S068)Boston Scientific Corp2005-09-15
PRIZM (P960040/S076)Boston Scientific2005-09-13
EPIC AND ATLAS FAMILIES OF DEVICES (P950022/S026)ABBOTT MEDICAL2005-09-13
CONTAK RENEWAL TR (P030005/S016)Guidant Corp.2005-09-13
STARR EDWARDS SILASTIC BALL VALVE, MODELS 1260 AND 6120 (P870038/S007)Edwards Lifesciences, LLC2005-09-13
CONTAK RENEWAL TR MODELS H120 AND H125 (P030005/S014)Guidant Corp.2005-09-13
CONTAK RENEWAL/CD 2/RENEWAL RF FAMILIES (P010012/S067)Boston Scientific Corp2005-09-13
DISCOVERY (P940031/S042)Boston Scientific2005-09-13
CONTAK RENEWAL TR (P030005/S011)Guidant Corp.2005-09-09
CONTAK RENEWAL TR MODELS H120 AND H125 (P030005/S015)Guidant Corp.2005-09-08
VENTAK PRIZM 2 DR/ VR PULSE GENERATOR (P960040/S077)Boston Scientific2005-09-08
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S051)Boston Scientific2005-09-08
GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (P010012/S062)Boston Scientific Corp2005-09-07
GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (P010012/S065)Boston Scientific Corp2005-09-07
GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S073)Boston Scientific2005-09-07
CONTAK RENEWAL TR (P030005/S012)Guidant Corp.2005-09-07
CONTAK RENEWAL TR IS-1 FAMILY (P030005/S013)Guidant Corp.2005-09-07
GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S074)Boston Scientific2005-09-07
DISCOVERY,MERIDIAN PULSE GENERATORS (P940031/S039)Boston Scientific2005-09-07
DISCOVERY/MERIDIAN (P940031/S040)Boston Scientific2005-09-07
GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND VENTAK PRIZM 2 AUTOMATIC IMPLANTABLE CARDIOVERT.. (P960040/S070)Boston Scientific2005-09-07
GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (P010012/S064)Boston Scientific Corp2005-09-07
XACT CAROTID STENT SYSTEM (P040038)Abbott Vascular, Inc.2005-09-06
SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER (P950029/S024)MicroPort CRM USA, Inc.2005-09-02
7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S010)Medtronic Cryocath, LP2005-09-02
DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT... (P990037/S023)Vascular Solutions, Inc.2005-09-02
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S044)Terumo Medical Corporation2005-09-02
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S006)W. L. Gore & Associates, Inc.2005-08-31
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S045)Terumo Medical Corporation2005-08-31
RELIANCE LEADS (P910073/S053)Boston Scientific2005-08-31
FLEXTEND LEADS (P960006/S017)Boston Scientific2005-08-31
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S022)Boston Scientific Corp2005-08-31
AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES (P880086/S105)ABBOTT MEDICAL2005-08-25
ON-X PROSTHETIC HEART VALVE (P000037/S007)On-X Life Technologies, Inc.2005-08-25
CONTAK RENEWAL (P010012/S059)Boston Scientific Corp2005-08-25
AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES (P880086/S106)ABBOTT MEDICAL2005-08-25
RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS (P980016/S053)Medtronic Cardiac Rhythm Disease Management2005-08-19
MATRIX VASCULAR CLOSURE SYSTEM (VSG) (P040044)Cordis US Corporation2005-08-17
CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR (P010012/S056)Boston Scientific Corp2005-08-16
CONTAK RENEWAL 3 RF CRT-D SYSTEM (P010012/S044)Boston Scientific Corp2005-08-15
MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE... (P910077/S050)Boston Scientific2005-08-15
INSYNC REGISTRY (P010015/S013)Medtronic, Inc.2005-08-12
PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S057)Abbott Vascular, Inc.2005-08-11
LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/... (P000009/S016)Biotronik, Inc.2005-08-11
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021)ABBOTT MEDICAL2005-08-05
CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), MODELS H135, H170, H175, H177, AND H179 (P010012/S054)Boston Scientific Corp2005-08-04
FLEXTEND FAMILY OF PACING LEADS (P960006/S016)Boston Scientific2005-08-04
RELIANCE ACTIVE FIX AND PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S052)Boston Scientific2005-08-03
MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036)Medtronic Cardiac Rhythm Disease Management2005-08-03
CONTAK RENEWAL 3 MODELS H170, H173 & H175 AND CONTAK RENEWAL 3 HE MODELS H177 & H179 (P010012/S055)Boston Scientific Corp2005-07-29
VENTAK PRIZM 2 DR AICD MODEL 1861 (P960040/S066)Boston Scientific2005-07-29
PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY AVT, VITALITY DS, VITALITY EL (P960040/S064)Boston Scientific2005-07-27
MERIDIAN/DISCOVERY (P940031/S037)Boston Scientific2005-07-27
CONTAK CD 2, CONTAK RENEWAL 3 DS, CONTAK RENEWAL 3 HE (P010012/S053)Boston Scientific Corp2005-07-27
CONTAK RENEWAL FAMILY (P010012/S057)Boston Scientific Corp2005-07-27
VITALITY HE MODELS T180 AND T182 (P960040/S067)Boston Scientific2005-07-27
KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E2 (P980035/S044)Medtronic, Inc.2005-07-26
MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE (P010031/S020)Medtronic Cardiac Rhythm Disease Management2005-07-26
2020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT (P890003/S082)Medtronic, Inc.2005-07-26
MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE (P980016/S048)Medtronic Cardiac Rhythm Disease Management2005-07-26
CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P960040/S062)Boston Scientific2005-07-22
VENTAK FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P010012/S051)Boston Scientific Corp2005-07-22
PRIZM, PRIZM 2, VITALITY, VITALITY 2 & VITALITY AVT (P960040/S061)Boston Scientific2005-07-21
CONTAK CD CRT-D MODELS H115, H119 AND CONTAK RENEWAL CRT-D MODELS H120, H125 (P010012/S049)Boston Scientific Corp2005-07-21
VITALITY AVT ICDS MODELS A135, A155 (P030005/S009)Guidant Corp.2005-07-21
VIGOR,DISCOVERY,AND MERIDIAN PACEMAKERS (P940031/S035)Boston Scientific2005-07-21
VITALITY ICD MODELS T125, T127, T135 AND VITALITY AVT ICD MODEL A155 (P960040/S058)Boston Scientific2005-07-21
CONTAK RENEWAL & CONTAK RENEWAL 3 RF (P010012/S050)Boston Scientific Corp2005-07-21
PRIZM ICS MODELS 1850, 1851, 18521853 (P960040/S059)Boston Scientific2005-07-21
STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120 (P870038/S005)Edwards Lifesciences, LLC2005-07-20
MEDTRONIC INSYNC MAXIMO MODEL 7304 AND MODEL 7303 (P010031/S024)Medtronic Cardiac Rhythm Disease Management2005-07-18
MEDTRONIC MODEL 2490G CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE (P890003/S087)Medtronic, Inc.2005-07-18
KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS (P980023/S019)Biotronik, Inc.2005-07-18
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