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Boston Scientific

1,882 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VITALITY HE MODEL T182 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT (P960040/S051)Boston Scientific2005-03-01
EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S010)Boston Scientific2005-02-28
PROGRAMMER SOFTWARE APPLICATION MODEL 2812 VERSION 1.3 (P960040/S049)Boston Scientific2005-02-18
MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S046)Boston Scientific2005-02-10
BLAZER II XP CARDIAC ABLATION CATHETERS (P020025/S008)Boston Scientific2005-01-10
INTERTACH (P860007/S023)Boston Scientific2004-12-22
SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND (P960006/S013)Boston Scientific2004-12-22
VENTAK PRX, VENTAK MINI (P910077/S049)Boston Scientific2004-12-22
DELTA, VISTA (P840068/S043)Boston Scientific2004-12-22
VIGOR, DISCOVERY, MERIDIAN (P940031/S033)Boston Scientific2004-12-22
ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S049)Boston Scientific2004-12-22
CYBERLITH (P800019/S012)Boston Scientific2004-12-22
VENTAK P2, VENTAK P3 (P930035/S014)Boston Scientific2004-12-22
VENTAK P (P890061/S016)Boston Scientific2004-12-22
RES-Q (P940008/S020)Boston Scientific2004-12-22
VENTAK, BIPOLAR ENDOCARDIAL (P830060/S057)Boston Scientific2004-12-22
COSMOS (P830026/S079)Boston Scientific2004-12-22
VENTAK AV, VENTAK VR, VENTAK PRIZM, VITALITY, VITALITY 2 (P960040/S050)Boston Scientific2004-12-22
RELAY (P910020/S026)Boston Scientific2004-12-22
SELUTE, SELUTE PICOTIP (P950001/S013)Boston Scientific2004-12-22
CYBERTACH (P820022/S004)Boston Scientific2004-12-22
FINELINE, FINELINE II (P960004/S027)Boston Scientific2004-12-22
COSMOS (P830026/S078)Boston Scientific2004-11-19
SELUTE,SELUTE PICOTIP (P950001/S012)Boston Scientific2004-11-19
INTERTACH (P860007/S022)Boston Scientific2004-11-19
VENTAK AV,VENTAK VR,VENTAK PRIZM,VITALITY,VITALITY 2 (P960040/S048)Boston Scientific2004-11-19
ENDOTAK,ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S048)Boston Scientific2004-11-19
DELTA, VISTA (P840068/S042)Boston Scientific2004-11-19
VENTAK P3 (P930035/S013)Boston Scientific2004-11-19
VIGOR,DISCOVERY,MERIDIAN (P940031/S032)Boston Scientific2004-11-19
RELAY (P910020/S025)Boston Scientific2004-11-19
RES-Q (P940008/S019)Boston Scientific2004-11-19
VENTAK BIPOLAR ENDOCARDIAL (P830060/S056)Boston Scientific2004-11-19
CYBERLITH (P800019/S011)Boston Scientific2004-11-19
SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND (P960006/S012)Boston Scientific2004-11-19
VENTAK P (P890061/S015)Boston Scientific2004-11-19
VENTAK PRX, VENTAK MINI (P910077/S047)Boston Scientific2004-11-19
CYBERTACH (P820022/S003)Boston Scientific2004-11-19
FINELINE,FINELINE II (P960004/S026)Boston Scientific2004-11-19
DIAGNOSTIC RESTORATION TOOL (DRT) MODEL 2725, VERSION 2.2 (P960040/S046)Boston Scientific2004-10-29
MODEL 2844 VERSION 3.8 (P960040/S047)Boston Scientific2004-10-29
EPT-1000XP CARDIAC ABLATION SYSTEM (P020025/S007)Boston Scientific2004-10-12
LEAD ADAPTERS MODEL NUMBER 6024 (P910073/S047)Boston Scientific2004-09-13
VITALITY ICD (P960040/S045)Boston Scientific2004-08-17
EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S006)Boston Scientific2004-07-27
EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S005)Boston Scientific2004-07-07
LEAD ADAPTERS MODEL 6833, 6836, 6931 (P830060/S055)Boston Scientific2004-07-06
LEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 6931 (P910073/S046)Boston Scientific2004-07-06
EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S004)Boston Scientific2004-06-09
VENTAK AV, VENTAK VR, VENTAK PRIZMALITY, VITALITY 2 (P960040/S044)Boston Scientific2004-05-14
ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S045)Boston Scientific2004-05-14
VENTAK PRX,VENTAK MINI (P910077/S045)Boston Scientific2004-05-14
VIGOR, DISCOVERY, MERIDIAN (P940031/S031)Boston Scientific2004-05-14
SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND (P960006/S010)Boston Scientific2004-05-14
VENTAK P (P890061/S014)Boston Scientific2004-05-14
FINELINE,FINELINE II (P960004/S025)Boston Scientific2004-05-14
SELUTE,SELUTE PICOTIP (P950001/S011)Boston Scientific2004-05-14
VENTAK P2,VENTAK P3 (P930035/S012)Boston Scientific2004-05-14
VENTAK BIPOLAR ENDOCARDIAL LEADS (P830060/S054)Boston Scientific2004-05-14
VITALITY 2 SYSTEM GUIDE (P960040/S043)Boston Scientific2004-05-04
VENTAK VITALITY AVT AICD SYSTEM (MODEL A135) (P960040/S042)Boston Scientific2004-03-19
VENTAK PRIZM AICD, VENTAK PRIZM HE AICE, VENTAK PRIZM 2 AICD AND VITALITY DS/EL AICD SYSTEMS (P960040/S041)Boston Scientific2004-03-09
VITALITY 2 AICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2) AND QUICK PROFILE (P960040/S039)Boston Scientific2004-03-08
ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187 (P910073/S043)Boston Scientific2004-03-02
EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S001)Boston Scientific2004-02-23
SELUTE (P950001/S010)Boston Scientific2004-02-10
MERIDIAN DISCOVERY (P940031/S030)Boston Scientific2004-02-10
FINELINE/ THINLINE (P960004/S024)Boston Scientific2004-02-10
SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND (P960006/S009)Boston Scientific2004-02-10
ENDOTAK/ ENDURANCE/ RELIANCE (P910073/S044)Boston Scientific2004-02-10
RES-Q (P940008/S018)Boston Scientific2004-02-10
VENTAK (P830060/S053)Boston Scientific2004-02-10
VENTAK AV/ PRIZM/PRIZM2/ VITALITY (P960040/S040)Boston Scientific2004-02-10
VENTAK PRX/ MINI III/ MINI IV (P910077/S044)Boston Scientific2004-02-10
VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910077/S041)Boston Scientific2004-02-06
VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S036)Boston Scientific2004-02-06
EPT-1000 XP RF ABLATION SYSTEMS (P020025/S003)Boston Scientific2004-01-07
PTCA CATHETERS (P880027/S063)Boston Scientific2004-01-07
EPT-1000 CARDIAC ABLATION SYSTEM (P020025/S002)Boston Scientific2003-12-31
VENTAK PRIZM MODELS 1850 AND 1851 (P960040/S038)Boston Scientific2003-12-24
VENTAK MINI I, II,III (P910077/S043)Boston Scientific2003-12-24
MERIDIAN, DISCOVERY (P940031/S029)Boston Scientific2003-12-19
FINELINE II PACING LEADS (P960004/S023)Boston Scientific2003-12-19
VENTTAK AV/PRIZM/PRIZM2,VITALITY (P960040/S037)Boston Scientific2003-12-19
VENTAK MINI III,MINI IV (P910077/S042)Boston Scientific2003-12-19
VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER (P960040/S034)Boston Scientific2003-12-17
VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910077/S040)Boston Scientific2003-12-17
BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942) (P830060/S052)Boston Scientific2003-11-21
HEX WRENCH(MODEL 6501) (P930035/S011)Boston Scientific2003-11-21
ENDOTAK RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S041)Boston Scientific2003-11-04
SOFTWARE APPLICATION MODEL 2890 VERSION 4.10 (P940031/S028)Boston Scientific2003-10-31
VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6 (P960040/S032)Boston Scientific2003-10-22
VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2 (P960040/S035)Boston Scientific2003-10-06
EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025)Boston Scientific2003-08-25
VITALITY DS ICD SYSTEMS (P960040/S031)Boston Scientific2003-07-10
THINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS (P960004/S022)Boston Scientific2003-07-02
VENTAK PRIZM AVT (P960040/S033)Boston Scientific2003-06-25
ENDOTAK RELIANCE STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S042)Boston Scientific2003-06-24
FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD (P960006/S008)Boston Scientific2003-05-30
VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P960040/S025)Boston Scientific2003-04-23
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Every clearance here is in the API, with alerts when new ones post.