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Boston Scientific

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

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RecordFirmDate
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S340)Boston Scientific2015-01-09
LATITUDE CONSULT SYSTEM (P910077/S148)Boston Scientific2015-01-06
DYNAGEN, INOGEN, ORIGEN ICDS (P960040/S341)Boston Scientific2015-01-06
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES (P960040/S337)Boston Scientific2015-01-06
MAESTRO 4000 CARDIAC ABLATION SYSTEM (P020025/S060)Boston Scientific2014-12-19
ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S338)Boston Scientific2014-12-19
BLAZER II XP TEMPERATURE ABLATION CATHETER (P020025/S065)Boston Scientific2014-12-17
ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S339)Boston Scientific2014-12-12
FINELINE II STEROID-ELUTING PACING LEADS (P960004/S067)Boston Scientific2014-12-11
BLAZER II XP CARDIAC ABLATION CATHETER (P020025/S061)Boston Scientific2014-12-08
DYNAGEN EL, INOGEN EL, ORIGEN EL ICDS (P960040/S332)Boston Scientific2014-11-07
LATITUDE CONSULT SYSTEM (P910077/S147)Boston Scientific2014-11-06
ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS (P910073/S128)Boston Scientific2014-11-04
DYNAGEN, INOGEN, ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S335)Boston Scientific2014-10-28
BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P020025/S064)Boston Scientific2014-10-21
DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S334)Boston Scientific2014-10-20
MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S059)Boston Scientific2014-10-17
ORIGEN EL,ORIGEN MINI, INOGEN EL,INOGEN MINI, DYNAGEN EL,DYNAGEN MINI, INCEPTA, ENERGEN, PUNCTUA ICDS (P960040/S333)Boston Scientific2014-10-16
INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN ICD'S (P960040/S331)Boston Scientific2014-09-18
ORIGEN, INOGEN, DYNAGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S330)Boston Scientific2014-09-10
VENTAK PRX & VENTAK MINI ICD: LATTITUDE PATIENT MANAGMENT SYSTEM (P910077/S146)Boston Scientific2014-09-05
ORIGEN ICD, INOGEN ICD, DYNAGEN ICDS (P960040/S329)Boston Scientific2014-09-04
COGNIS, INCEPTA, ENERGEN, PUCTUA, DYNAGEN, INOGEN, ORIGEN; CRT-D'S (P960040/S328)Boston Scientific2014-08-27
NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD,ORIGEN EL (P960040/S320)Boston Scientific2014-08-26
NG3 DEVICES: ORIGEN, INOGEN, DYNAGEN ICDS; PROGENY DEVICES: PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD (P960040/S326)Boston Scientific2014-08-13
VENTAK PRX AND VENTAK MINI SYSTEMS (P910077/S144)Boston Scientific2014-08-12
VERTICALLY INTEGRATING BATTERY FEEDTHRU ASSEMBLY (P960040/S325)Boston Scientific2014-08-11
VENTAK AV/PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA, ENERGEN, & INCEPTA ICD'S (P960040/S323)Boston Scientific2014-07-30
SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEADS (P960006/S043)Boston Scientific2014-07-30
THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S066)Boston Scientific2014-07-30
VENTAK PRX AND VENTAK MINI (P910077/S145)Boston Scientific2014-07-30
ENDOTAK LEAD SYSTEM (P910073/S127)Boston Scientific2014-07-30
VENTAK (P830060/S080)Boston Scientific2014-07-30
SELUTE LEAD SYSTEM (P950001/S027)Boston Scientific2014-07-30
VENTAK P2 PACEMAKER (P930035/S027)Boston Scientific2014-07-30
DYNAGEN, INOGEN, ORIGEN EL ICD'S AND DYNAGEN, INOGEN, ORIGEN MINI ICD'S (P960040/S324)Boston Scientific2014-07-28
INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S063)Boston Scientific2014-07-18
LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0 (P910077/S143)Boston Scientific2014-07-16
TELIGEN, PROGENY ICD AND NG ICD MODELS (P960040/S316)Boston Scientific2014-07-16
INTELLATIP MIFI FILTER MODULE, INTELLATIP MIFI REFERENCE CABLE (P020025/S062)Boston Scientific2014-07-14
NG3 ICDS, ORIGEN, INOGEN, DYNAGEN EL; NG2.5 ICDS -ORIGEN, INOGEN, DYNAGEN MINI ICDS (P960040/S321)Boston Scientific2014-07-11
INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN ICDS (P960040/S319)Boston Scientific2014-07-08
PUNCTUA ICDS,TELIGEN ICDS,ENERGEN ICDS,INCEPTA ICDS,ORIGEN ICDS,INOGEN ICDS,DYNAGEN ICDS (P960040/S322)Boston Scientific2014-07-08
ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES (P910073/S126)Boston Scientific2014-06-30
LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM (P910077/S140)Boston Scientific2014-06-20
DYNAGEN, INOGEN, ORIGEN (P960040/S318)Boston Scientific2014-06-17
ORIGEN, INOGEN,DYNAGEN, NG3 IMPLANTABLE CARDIOVESTER DEFIBRILLATOR (ICD) ORIGEN, INOGEN, DYNAGEN NG2.5 IMPLANTABLE CARDI (P960040/S317)Boston Scientific2014-06-02
BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S058)Boston Scientific2014-05-30
PUNCTUA ICDS, TELIGEN ICDS, ENERGEN ICDS, INCEPTA ICDS, ORIGEN ICDS, INOGEN ICDS, DYNAGEN ICDS (P960040/S314)Boston Scientific2014-05-28
DYNAGEN,INOGEN,ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P960040/S315)Boston Scientific2014-05-23
TELIGEN,INCEPTA,PUNCTUA,ENERGEN ICDS, INCEPTA, PUNCTUA,ENERGEN CRT-DS (P960040/S312)Boston Scientific2014-05-15
THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS (P960004/S065)Boston Scientific2014-05-07
VENTAK P2 AICD SYSTEM (P930035/S026)Boston Scientific2014-05-07
AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM (P830060/S079)Boston Scientific2014-05-07
VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM (P940031/S077)Boston Scientific2014-05-07
VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK (P910077/S142)Boston Scientific2014-05-07
FLEXTEND PACING LEADS AND FIXATION TOOL (P960006/S042)Boston Scientific2014-05-07
RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS (P940008/S031)Boston Scientific2014-05-07
ENDOTAK TRANSVENOUS DEFIBRILLATION SYSTEM (P910073/S125)Boston Scientific2014-05-07
AID-B/BR AND VENTAK ICD (P830060/S077)Boston Scientific2014-05-02
VENTAK PRX, VENTAK MINI FAMILIES OF ICDS (P910077/S141)Boston Scientific2014-05-02
VIGOR, MERIDIAN, DISCOVER FAMILIES OF PACEMAKER (P940031/S076)Boston Scientific2014-05-02
VENTAK AV, VENTAK PRIZM, VITALITY, CONFIENT, TELIGEN, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF ICDS (P960040/S310)Boston Scientific2014-05-02
ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS (P910073/S124)Boston Scientific2014-05-02
PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICD'S (P960040/S313)Boston Scientific2014-05-01
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S057)Boston Scientific2014-05-01
RELIANCE IS-1/DF-1 LEAD FAMILY,RELIANCE 4-SITE LEAD FAMILY (P910073/S123)Boston Scientific2014-04-24
FLEXTEND (P960006/S041)Boston Scientific2014-04-24
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S056)Boston Scientific2014-04-23
DYNAGEN EL & MINI ICD'S; INOGEN EL & MINI ICD'S; ORIGEN EL & MINI ICD'S; TELIGEN ICD (P960040/S306)Boston Scientific2014-04-11
MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM) (P910077/S139)Boston Scientific2014-04-11
BLAZER II XP,BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S055)Boston Scientific2014-04-04
INCEPTA,ENERGEN,PUNCTUA,TELIGEN IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATORS (P960040/S311)Boston Scientific2014-03-31
VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT (P830060/S078)Boston Scientific2014-03-31
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S054)Boston Scientific2014-03-26
LATTITUDE CONSULT SYSTEM (P910077/S138)Boston Scientific2014-03-20
PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S309)Boston Scientific2014-03-12
BLAZER II XPCARDIAC ABLATION CATHETER AND CABLE (P020025/S053)Boston Scientific2014-02-13
BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S052)Boston Scientific2014-02-07
PUNCTUA, ENERGEN, INCEPTA, AND TELIGEN ICD (P960040/S297)Boston Scientific2013-12-23
BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P020025/S051)Boston Scientific2013-12-18
PUNTUA ICD'S, TELIGEN ICD'S, ENERGEN ICD'S AND INCEPTA ICD'S (P960040/S308)Boston Scientific2013-12-17
MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S049)Boston Scientific2013-12-05
FINELINE II STEROX (P960004/S064)Boston Scientific2013-12-04
INTELLA TIP MIFI XP ABLATION CATHETER (P020025/S050)Boston Scientific2013-12-03
PUNCTUA,TELIGEN,ENERGEN,INCEPTA,VITALITY ICDS (P960040/S307)Boston Scientific2013-11-26
EPT-1000 XP RF ABLATION SYSTEM (P020025/S046)Boston Scientific2013-11-25
EPT-1000 XP RF ABLATION SYSTEM (P020025/S045)Boston Scientific2013-11-25
BLAZER IIXP/BLAZER PRIME XP ABLATION CATHETERS AND EPT-1000 XP CARDIAC ABLATION CONTROLLER (P020025/S048)Boston Scientific2013-10-23
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S047)Boston Scientific2013-10-18
EPT-1000XP CARDIAC ABLATION SYSTEM (P020025/S044)Boston Scientific2013-10-07
MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES, AND BLAZER II XP, BLAZER PRIME XP ABLATION CATHETERS (P020025/S043)Boston Scientific2013-09-27
TELIGEN, INCEPTA,ENERGEN AND PUNCTUA ICDS (P960040/S305)Boston Scientific2013-09-26
SELUTE LEAD SYSTEM (P950001/S026)Boston Scientific2013-09-25
DELTA/ VISTA (P840068/S053)Boston Scientific2013-09-25
VENTAK P AICD SYSTEMS (P890061/S023)Boston Scientific2013-09-25
ENDOTAK LEAD SYSTEM (P910073/S121)Boston Scientific2013-09-25
VENTAK AV AND VENTAK PRIZM DR/VR,VITALITY,CONFIENT,TELIGEN,PUNCTUA ICD,ENERGEN ICD,AND INCEPTA ICD AICD SYSTEMS (P960040/S304)Boston Scientific2013-09-25
VIGOR DR/SR,DISCOVERY,MERIDIAN (P940031/S075)Boston Scientific2013-09-25
VENTAK P2 AICD SYSTEMS (P930035/S025)Boston Scientific2013-09-25
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Every clearance here is in the API, with alerts when new ones post.