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Boston Scientific

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

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RecordFirmDate
VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P830060/S076)Boston Scientific2013-09-25
COSMOS (P830026/S082)Boston Scientific2013-09-25
SWEET TIP RX,SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEMS (P960006/S040)Boston Scientific2013-09-25
THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S063)Boston Scientific2013-09-25
VENTAK PRX AND VENTAK MINI AICD (P910077/S137)Boston Scientific2013-09-25
PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S303)Boston Scientific2013-09-19
ENTOTAK LEAD SYSTEM (P910073/S120)Boston Scientific2013-09-17
FINELINE II STEROX LEAD (P960004/S060)Boston Scientific2013-09-09
ZOOM LATITUDE PROGRAMMER (P910077/S136)Boston Scientific2013-08-21
MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S042)Boston Scientific2013-08-14
VENTAK (P830060/S075)Boston Scientific2013-08-07
SWEET TIP RX/ FLEXTEND LEAD FAMILY (P960006/S039)Boston Scientific2013-08-07
FINLINE LEAD FAMILY (P960004/S061)Boston Scientific2013-08-07
INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER (P020025/S036)Boston Scientific2013-08-07
ENDOTAK LEAD FAMILY (P910073/S117)Boston Scientific2013-08-07
VENTAK PRX MINI (P910077/S133)Boston Scientific2013-08-07
INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S300)Boston Scientific2013-07-30
INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S302)Boston Scientific2013-07-30
TELIGEN,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S298)Boston Scientific2013-07-24
TELIGEN, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD (P960040/S299)Boston Scientific2013-07-24
RELIANCE IS-1/DF-1,RELIANCE 4-SITE PASSIVE FIXATION LEADS (P910073/S118)Boston Scientific2013-07-16
TELIGEN, INCEPTA, ENERGEN, PUNCTUA (P960040/S296)Boston Scientific2013-07-03
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, INCEEPTA, ENERGEN, PUNCTUA, TELIGEN , ICD'S (P960040/S295)Boston Scientific2013-06-21
LATITUDE COMMUNICATOR (P910077/S135)Boston Scientific2013-06-20
ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S134)Boston Scientific2013-06-20
CONFIENT, VIVIAN, INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY FAMILIES. (P960040/S294)Boston Scientific2013-06-06
FLEXTEND LEAD (P960006/S038)Boston Scientific2013-05-07
RELIANCE IS-1/DF-1 LEAD AND RELIANCE 4-SITE LEAD (P910073/S116)Boston Scientific2013-05-07
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S131)Boston Scientific2013-04-30
PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICD'S (P960040/S293)Boston Scientific2013-04-30
PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S290)Boston Scientific2013-04-26
PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S292)Boston Scientific2013-04-26
INCEPTA, ENERGEN, AND PUNCTUA MODELS OF ICD¿S (P960040/S289)Boston Scientific2013-04-19
BLAZERII TEMPERATURE ABLATION CATHETER, BLAZERII XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATION (P020025/S040)Boston Scientific2013-04-18
PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S291)Boston Scientific2013-04-12
BLAZER PRIME XP CARDIAC ABLATION CATHETERS (P020025/S039)Boston Scientific2013-04-01
LATITUDE COMMUNICATOR (P910077/S132)Boston Scientific2013-03-13
PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBTILLATOR, TELIGEN IMPLANTABLE CARIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARDI (P960040/S288)Boston Scientific2013-03-07
PUNCTUA ICD, TELIGEN ICD, ENERGEN ICD, INCEPTA ICD (P960040/S287)Boston Scientific2013-03-07
EPT-1000 XP RF ABLATION SYSTEM (P020025/S038)Boston Scientific2013-02-22
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) (P960040/S286)Boston Scientific2013-02-20
ENDOTAK RELIANCE, ENDOTAK RELIANCE 4-SITE (P910073/S115)Boston Scientific2013-02-14
MULTIPLE APPLICATION UTILITY (MAU) USED WITH ZOOM LATITIDE PROGRAMMING SYSTEM (P910077/S130)Boston Scientific2013-02-12
ICD PUNCTUA VR IS4 (P960040/S285)Boston Scientific2013-02-08
LATITUDE WAVE COMMUNICATOR (MODEL 6498) (P910077/S119)Boston Scientific2013-01-28
BLAZER PRIME XP AND BLAZER II XP CARDIAC ABLATION CATHETERS (P020025/S037)Boston Scientific2013-01-22
TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD (P960040/S284)Boston Scientific2013-01-22
INCEPTA, ENERGEN, PUNCTUA, TELIGEN ICD'S (P960040/S283)Boston Scientific2013-01-10
TELIGEN 4-SITE HEADER ICD MODELS (P960040/S262)Boston Scientific2012-12-21
ENDOTAK RELIANCE 4-SITE LEAD AND ACCESSORY MODELS (P910073/S102)Boston Scientific2012-12-21
RELIANCE 4-SITE DEFIBRILLATOR LEAD (P910073/S107)Boston Scientific2012-12-20
RELIANCE IS-1/IS-4 ACTIVE AND PASSIVE FIXATION DEFIBRILATION LEADS (P910073/S114)Boston Scientific2012-12-18
RELIANCE DF4 LEADS (P910073/S113)Boston Scientific2012-12-12
TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD (P960040/S282)Boston Scientific2012-12-11
VENTAK PRX AND VENTAK MINI ICD FANILIES (P910077/S129)Boston Scientific2012-12-05
COSMOS (P830026/S081)Boston Scientific2012-12-05
VENTAK P2 ICD FAMILIES (P930035/S024)Boston Scientific2012-12-05
VENTAK ICD FAMILIES (P890061/S022)Boston Scientific2012-12-05
SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD FAMILIES (P960006/S037)Boston Scientific2012-12-05
VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES (P940031/S074)Boston Scientific2012-12-05
DELTA / VISTA FAMILIES (P840068/S052)Boston Scientific2012-12-05
SELUTE LEAD FAMILY (P950001/S025)Boston Scientific2012-12-05
ENDOTAK AND RELIANCE LEAD FAMILIES (P910073/S112)Boston Scientific2012-12-05
THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S058)Boston Scientific2012-12-05
VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM FAMILY (P830060/S074)Boston Scientific2012-12-05
VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, AND TELIGEN, PUNCTUA, ENERGEN, AND INCEPTA ICD FAMILIES (P960040/S281)Boston Scientific2012-12-05
TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S270)Boston Scientific2012-11-30
TELIGEN, INCEPT, ENERGEN AND PUNCTUA ICDS (P960040/S280)Boston Scientific2012-11-29
RELIANCE IS-4 DEFIBRILLATION LEAD (P910073/S111)Boston Scientific2012-11-14
LATITUDE/PROGRAMMER/RECORDER/MONITOR (P910077/S128)Boston Scientific2012-11-14
INCEPTA, ENERGEN, PUNCTUA, TELIGEN, CONFIENT (P960040/S266)Boston Scientific2012-11-14
SELUTE LEAD FAMILY (P950001/S024)Boston Scientific2012-11-09
ENDOTAK FAMILY OF ICD LEADS (P910073/S109)Boston Scientific2012-11-09
VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, LIVIAN, & TELIGEN FAMILIES OF ICDS (P960040/S276)Boston Scientific2012-11-09
VENTAK PRIZM 2 FAMILIES, ICD (P890061/S021)Boston Scientific2012-11-09
SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND FAMILIES OF PACING LEADS (P960006/S036)Boston Scientific2012-11-09
DELTA, VISTA FAMILIES, PACEMAKER (P840068/S051)Boston Scientific2012-11-09
VENTAK PRX/VENTAK MINI FAMILIES OF ICDS (P910077/S126)Boston Scientific2012-11-09
RES-Q FAMILY OF ICD/ICD LEADS, RES-Q MICRON FAMILY OF ICDS (P940008/S030)Boston Scientific2012-11-09
VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES OF PACEMAKERS (P940031/S073)Boston Scientific2012-11-09
VENTAK PRIZM 2 FAMILIES, ICD (P930035/S023)Boston Scientific2012-11-09
VENTAK , VENTAK PRIZM, ICD (P830060/S073)Boston Scientific2012-11-09
THINLINE/FINELINE FAMILIES OF PACING LEADS (P960004/S057)Boston Scientific2012-11-09
ACUITY SPIRAL (P910073/S110)Boston Scientific2012-11-07
LATITUDE G2 COMMUNICATOR (P910077/S127)Boston Scientific2012-11-07
PRIZM HE, VITALITY, VITALITY 2, CONFIENT, PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICDS (P960040/S275)Boston Scientific2012-11-07
PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S279)Boston Scientific2012-11-07
ICD MODELS, INCEPTA E-160, E-161, E162, E163, ENERGEN E140, E141, E142, E143, PUNCTUA E050, E050, E051, E052, E053 (P960040/S277)Boston Scientific2012-11-05
ENDOTAK LEAD SYSTEM (P910073/S108)Boston Scientific2012-11-05
INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S278)Boston Scientific2012-11-05
MODEL 3120 ZOOM LATTITUDE PROGRAMMING SYSTEM (P910077/S124)Boston Scientific2012-10-24
PUNCTUA, TELIGEN, ENERGEN, AND INCEPTA ICD'S (P960040/S273)Boston Scientific2012-10-24
TELIGEN IMPLANTABLE CARDIAC DEFIBRILLATORS (P960040/S274)Boston Scientific2012-10-24
VENTAK PRX AND VENTAK. MINI AUTOMATIC IMPLANTABLE CARDIOVERTER (P910077/S125)Boston Scientific2012-10-24
TELIGEN, INCEPTA, ENERGEN, PUNCTUA IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR (P960040/S272)Boston Scientific2012-10-17
THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS AND ACCESSORIES (P960004/S056)Boston Scientific2012-10-10
ENDOTAK LEAD SYSTEM FAMILY (P910073/S105)Boston Scientific2012-10-05
THINLINE/FINELINE LEADS FAMILIES (P960004/S054)Boston Scientific2012-10-05
VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P830060/S072)Boston Scientific2012-10-05
VENTAK P /P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILIES (P930035/S022)Boston Scientific2012-10-05
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