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Boston Scientific

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

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RecordFirmDate
RES-Q/RES-Q MICRON FAMILIES (P940008/S027)Boston Scientific2011-04-29
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S227)Boston Scientific2011-04-08
BLAZER II XP CARDIAC ABLATION CATHETER & CABLE/BLAZER PRIME XP CARDIAC ABLATION CATHETER (P020025/S025)Boston Scientific2011-03-31
THINLINE II, STEROX, FINELINE II STEROX AND FINELINE II STEROX EZ (P960004/S048)Boston Scientific2011-03-24
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S110)Boston Scientific2011-03-03
RELIANCE 4-SITE (P910073/S092)Boston Scientific2011-02-11
BLAZER II XP CATHETERS (P020025/S021)Boston Scientific2011-01-26
PRIZM HE/3/VITALITY/2/AVT/CONFIENT/TELIGEN (P960040/S240)Boston Scientific2011-01-19
VENTAK AV/VENTAK PRIZM DR/VR/VITALITY ICDS (P960040/S239)Boston Scientific2011-01-14
RELIANCE IS -1 AND RELIANCE IS-4 (P910073/S090)Boston Scientific2010-12-15
LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481 SOFTWARE, VERSION 1.6. (P910077/S109)Boston Scientific2010-11-19
PRIZM AND VITALITY FAMILY (P960040/S238)Boston Scientific2010-11-19
TELIGEN 4-SITE MODELS (P960040/S198)Boston Scientific2010-11-10
LEAD TUNNELER MODEL 6888 (P830060/S062)Boston Scientific2010-11-10
ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES (P910073/S077)Boston Scientific2010-11-10
FLEXTEND EXTENDABLE/RETRACTABLE ENDOCARDIAL PACING LEADS (P960006/S027)Boston Scientific2010-10-20
TELIGEN PULSE GENERATORS (P960040/S224)Boston Scientific2010-10-15
PULSE GENERATOR (P960040/S237)Boston Scientific2010-10-08
LATITUDE COMMUNICATORS & PROGRAMMER (P910077/S107)Boston Scientific2010-09-29
RELIANCE LEADS (P910073/S084)Boston Scientific2010-09-28
THINLINE/FINELINE (P960004/S046)Boston Scientific2010-09-22
TELIGEN HE DR/VR /CONFIENT (P960040/S233)Boston Scientific2010-09-22
VITALITY/PRIZM/CONFIENT/TELIGEN (P960040/S232)Boston Scientific2010-09-17
VENTAK AV AICD SYSTEM (P960040/S234)Boston Scientific2010-09-14
CONFIENT (P960040/S231)Boston Scientific2010-09-14
VIGOR DR/SR PACEMAKER SYSTEM (P940031/S069)Boston Scientific2010-09-14
DELTA PACEMAKER SYSTEM (P840068/S047)Boston Scientific2010-09-14
VENTAK PRX AICD SYSTEM (P910077/S108)Boston Scientific2010-09-14
RELIANCE ENDOTAK IMPLANTABLE LEADS (P910073/S086)Boston Scientific2010-09-08
TELIGEN (P960040/S230)Boston Scientific2010-09-08
TELIGEN (P960040/S218)Boston Scientific2010-09-07
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S228)Boston Scientific2010-09-03
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S229)Boston Scientific2010-09-02
BLAZER II XP/BLAZER PRIME XP ABLATION CATHETERS (P020025/S024)Boston Scientific2010-08-26
IMPLANTABLE PULSE GENERATOR PACEMAKER (P940031/S068)Boston Scientific2010-08-13
VENTAK AV/VENTAK PRIZM DR/VR/VITALITY/CONFIENT/TELIGEN (P960040/S226)Boston Scientific2010-08-13
BSC CRV ENDOTAK LEADS (P910073/S085)Boston Scientific2010-08-13
VENTAK PRX & VENTAK MINI I-IV (P910077/S106)Boston Scientific2010-08-13
TELIGEN PULSE GENERATORS (P960040/S225)Boston Scientific2010-08-06
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910077/S105)Boston Scientific2010-07-22
BLAZER PRIME XP CATHETER (P020025/S023)Boston Scientific2010-06-30
RELIANCE LEADS (P910073/S083)Boston Scientific2010-05-21
CONFIENT AND VITALITY FAMILIES OF ICDS (P960040/S223)Boston Scientific2010-05-20
DUAL-CHAMBER ADAPTIVE-RATE PACEMAKER (P940031/S067)Boston Scientific2010-05-20
MODEL 3120 ZOOM LATITUDE PROGRAMMER (P910077/S104)Boston Scientific2010-05-19
CONFIENT AND VITALITY HE FAMILIES OF PULSE GENERATORS (P960040/S221)Boston Scientific2010-05-19
VENTAK PRIZM, VENTAK PRIZM 2, VITALITY, VITALITY HE, VITALITY 2, VITALITY AVT, AND CONFIENT FAMILIES OF ICDS (P960040/S222)Boston Scientific2010-05-19
TELIGEN PULSE GENERATORS MODELS E110 (P960040/S219)Boston Scientific2010-04-15
VENTAK (CONFIENT/TELIGEN/VITALITY) (P960040/S220)Boston Scientific2010-04-15
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S102)Boston Scientific2010-04-06
TELIGEN PULSE GENERATORS (P960040/S214)Boston Scientific2010-04-02
LATITUDE¿ COMMUNICATOR RF (P910077/S103)Boston Scientific2010-04-01
TELIGEN (P960040/S213)Boston Scientific2010-03-12
VIGOR FAMILY (P940031/S066)Boston Scientific2010-03-04
VENTAK FAMILY (P960040/S217)Boston Scientific2010-03-04
TELIGEN/CONFIENT (P960040/S215)Boston Scientific2010-03-04
EPT-1000 XP CARDIAC ABLATION SYSTEM CONTROLLER AND ACCESSORIES AND MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES (P020025/S022)Boston Scientific2010-02-22
VENTAK/PRX/VENTAK MINI I-IV (P910077/S101)Boston Scientific2010-01-15
VENTAK (P830060/S065)Boston Scientific2010-01-15
SWEET TIP RX/FLEXTEND (P960006/S026)Boston Scientific2010-01-15
ENDOTAK (P910073/S082)Boston Scientific2010-01-15
THINLINE/FINELINE (P960004/S045)Boston Scientific2010-01-15
SELUTE (P950001/S021)Boston Scientific2010-01-15
VENTAK P2 (P930035/S019)Boston Scientific2010-01-15
VENTAK P (P890061/S018)Boston Scientific2010-01-15
RES-Q/RES-Q MICRON (P940008/S026)Boston Scientific2010-01-15
#2 BI-DIRETIONAL TORQUE WRENCH (P930035/S018)Boston Scientific2010-01-12
BIFURCATED BIPOLAR ENDOCARDIAL TINED LEAD/BIPOLAR ENDOCARDIAL LEAD/POSITIVE FIXATION PROTECTED HELIX BIPOLAR ENDOCARDIAL (P830060/S064)Boston Scientific2010-01-12
THINLINE II STEROX/THINLINE II STEROX/EZ/FINELINE II STEROX/EZ/TAPERED STYLET (P960004/S044)Boston Scientific2010-01-12
SELUTE PICOTIP BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/SELUTE BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/ATRAIL J SELUTE (P950001/S020)Boston Scientific2010-01-12
LEAD CAP ACCESSORY KIT (P940008/S025)Boston Scientific2010-01-12
SUPERIOR VENA CAVA LEAD (P890061/S017)Boston Scientific2010-01-12
ENDOTAK RELIANCE/S/ENDOTAK ENDURANCE EZ/ENDOTAK RELIANCE SG/G (P910073/S081)Boston Scientific2010-01-12
SWEET PICOTIP RX/FLEXTEND/SWEET TIP RX/FIXATION TOOL (P960006/S025)Boston Scientific2010-01-12
ENDOTAK SQ PATCH LEAD/SQ ARRAY LEAD/SQ ARRAY XP/SMALL & LARGE PATCH LEADVENTAK NINI III/IV/ AICD PULSE GENERATORS (P910077/S100)Boston Scientific2010-01-12
VENTAK PRIZM VR/DR AICD PULSE GENERATOR/DR/HE/VITALITY VR AICD PULSE GENERATOR (P960040/S212)Boston Scientific2010-01-12
TELIGEN ICDS (P960040/S211)Boston Scientific2009-12-23
TELIGEN (P960040/S209)Boston Scientific2009-12-22
TELIGEN (P960040/S210)Boston Scientific2009-12-22
VITALITY AND CONFIENT (P960040/S207)Boston Scientific2009-12-22
TELIGEN FAMILY OF ICDS (P960040/S208)Boston Scientific2009-12-22
TELIGEN PACEMAKER (P960040/S206)Boston Scientific2009-12-14
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S097)Boston Scientific2009-11-25
MODEL 6476 G2 RF LATITUDE COMMUNICATOR (P910077/S098)Boston Scientific2009-11-16
VIGOR DR/SR/DISCOVER/MERIDIAN/PDP (P940031/S065)Boston Scientific2009-11-16
PRIZM/VITALITY (P960040/S199)Boston Scientific2009-11-16
COGNIS/TELIGEN (P960040/S202)Boston Scientific2009-11-10
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910077/S096)Boston Scientific2009-10-30
TELIGEN ICDS (P960040/S205)Boston Scientific2009-10-28
TELIGEN/CONFIENT/VITALITY PULSE GENERATORS (P960040/S204)Boston Scientific2009-10-21
BLAZER PRIME XP CARDIAC ABLATION CATHETERS (P020025/S020)Boston Scientific2009-10-02
RELIANCE LEADS (P910073/S079)Boston Scientific2009-09-22
TELIGEN (P960040/S203)Boston Scientific2009-09-16
CONFIENT SW AND LIVIAN SW (P960040/S175)Boston Scientific2009-08-18
CONFIENT/VITALITY (P960040/S177)Boston Scientific2009-07-30
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S094)Boston Scientific2009-07-21
TELIGEN FAMILIES (P960040/S201)Boston Scientific2009-07-10
EP TECH EPT-1000XP RF ABLATION SYSTEM (P020025/S015)Boston Scientific2009-07-08
TELIGEN PULSE GENERATORS (P960040/S197)Boston Scientific2009-07-07
MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S095)Boston Scientific2009-07-06
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Every clearance here is in the API, with alerts when new ones post.