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Boston Scientific

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

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RecordFirmDate
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S090)Boston Scientific2016-08-11
INGEVITY ACTIVE FIXATION LEAD (P150012/S012)Boston Scientific2016-08-11
ENDOTAK RELIANCE 4-SITE LEADS PASSIVE FIXATION & ENDOTAK RELIANCE 4-SITE ACTIVE FIXATION (P910073/S137)Boston Scientific2016-08-02
DYNAGEN, INOGEN, ORIGEN ICD'S (P960040/S377)Boston Scientific2016-08-02
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI PACEMAKER'S (P150012/S011)Boston Scientific2016-08-02
FINELINE II (P960004/S077)Boston Scientific2016-08-02
DYNAGEN™ EL ICD: D150, D151, D152, D153; INOGEN™ EL ICD: D140, D141, D142, D143; ORIGEN™ EL ICD: D050, D051, D052, D053; (P960040/S378)Boston Scientific2016-08-01
INGEVITY MRI LEAD, INGEVITY Non-MRI Lead (P150012/S010)Boston Scientific2016-07-26
INGEVITY LEAD (P150012/S009)Boston Scientific2016-07-25
ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE LEAD (P910073/S136)Boston Scientific2016-07-25
Dynagen™ Models: D020, D021, D022, D023; D150, D151, D152, D153; Inogen™ Models: D010, D011, D012, D013, D140, D141, D14 (P960040/S375)Boston Scientific2016-07-22
INGENIO 2 MRI PACEMAKERS. (P150012/S004)Boston Scientific2016-07-14
ACUITY X4 LEAD (P150012/S006)Boston Scientific2016-07-13
LATITUDE NXT RELEASE 4.1.1 (P910077/S152)Boston Scientific2016-07-08
ICD DEVICES: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, OPRIGEN, INOGEN, DYNAGEN, AUTOGEN. (P960040/S370)Boston Scientific2016-07-08
INTELLATIP MIFI XP TEMPERATURE ABLATION SYSTEM (P020025/S088)Boston Scientific2016-07-07
RES-Q and RES-Q MICRON ICD and ICD Lead Family (P940008/S032)Boston Scientific2016-06-23
SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families (P960006/S046)Boston Scientific2016-06-23
THINLINE/FINELINE Family of ENDOCARDIAL PACING LEADS (P960004/S076)Boston Scientific2016-06-23
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S008)Boston Scientific2016-06-23
VENTAK(R) P2 ICD FAMILY (P930035/S028)Boston Scientific2016-06-23
SELUTE Pacing Lead Family (P950001/S028)Boston Scientific2016-06-23
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S087)Boston Scientific2016-06-23
ENDOTAK LEAD SYSTEM (P910073/S135)Boston Scientific2016-06-23
VENTAK ICD Family (P830060/S081)Boston Scientific2016-06-23
VENTAK PRX and VENTAK MINI ICD Families (P910077/S153)Boston Scientific2016-06-23
ESSENTIO VALITUDE™ MRI: L110, L111, L131;PROPONENT VALITUDE™ MRI: L210, L211, L231; ACCOLADE VALITUDE™ MRI: L310, L311, (P150012/S007)Boston Scientific2016-06-20
ORIGEN ™ EL ICD: D050, D051, D052, D053; INOGEN ™ EL ICD: D140, D141, D142, D143; DYNAGEN ™ EL ICD: D150, D151, D152, D1 (P960040/S373)Boston Scientific2016-06-20
INGEVITY LEADS (P150012/S005)Boston Scientific2016-06-15
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers (P150012/S002)Boston Scientific2016-05-31
ESSENTIO VALITUDE MRI, PROPONENT VALITUDE MRI, ACCOLADE VALITUDE MRI (P150012/S001)Boston Scientific2016-05-25
NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). ORIGEN , INOGEN, DYNAGEN EL ICD'S. NG2.5 IMPLANTABLE CARDIOVERTER DEFIB (P960040/S372)Boston Scientific2016-05-25
PACEMAKER MODELS. ESSENTIO , PROPONENT, ACCOLADE MRI'S (P150012/S003)Boston Scientific2016-05-25
NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ORIGEN EL ICD: D050, D051, D052, D053 INOGEN EL ICD: D140, D141, D142, (P960040/S371)Boston Scientific2016-05-17
Origen, Dynagen, Inogen EL ICD; Origen, Dynagen, Inogen MINI ICD (P960040/S369)Boston Scientific2016-05-09
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S365)Boston Scientific2016-05-03
ENDOTAK RELIANCE IS-1 AND ENDOTAK RELIANCE 4-SITE LEAD MODELS (P910073/S133)Boston Scientific2016-04-29
FINELINE II STEROX AND STEROX EZ LEADS (P960004/S075)Boston Scientific2016-04-29
BLAZER PRIME XP,INTELLATIP MIFI XP, BLAZER II XP TEMPERATURE ABLATION CATHETERS (P020025/S082)Boston Scientific2016-04-28
ENDOTAK RELIANCE™ G/SG with 4-SITE™ Connector Defibrillation Leads, Passive Fixation Lead Models: 0265, 0266, 0282, 0283 (P910073/S134)Boston Scientific2016-04-27
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012)Boston Scientific2016-04-25
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S367)Boston Scientific2016-04-20
EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S086)Boston Scientific2016-04-19
Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs) (P960040/S368)Boston Scientific2016-04-14
EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S085)Boston Scientific2016-04-08
DYNAGEN™ ICD Models D150, D151, D152, D153; INOGEN™ ICD Models D140, (P960040/S361)Boston Scientific2016-03-28
ORIGEN ™ EL ICD D050, D051, D052, D053; ORIGEN ™ MINI ICD D000, D001, D002, D003; DYNAGEN ™ EL ICD D150, D151, D152, D15 (P960040/S366)Boston Scientific2016-03-23
Dynagen™ Models D150, D151, D152, D153; Inogen™ Models D140, D141, D142, D143; Origen™ Models D050, D051, D052, D053 ICD (P960040/S364)Boston Scientific2016-03-09
EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S084)Boston Scientific2016-03-04
EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S083)Boston Scientific2016-03-04
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN, (P960040/S363)Boston Scientific2016-03-03
INTELLANAV XP TEMPERATURE ABLATION CATHETER, INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER, INTELLANAV ABLATION CATHE (P020025/S077)Boston Scientific2016-02-24
RELIANCE 4-SITE LEAD FAMILY (P910073/S132)Boston Scientific2016-02-22
CHILLI II COOLED ABLATION SYSTEM (P020025/S076)Boston Scientific2016-02-08
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES (P960040/S362)Boston Scientific2016-02-05
LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460 (P910077/S151)Boston Scientific2016-02-05
ORIGEN, INOGEN, AND DYNAGEN ICD, INCEPTA, ENERGEN, AND PUNCTUA ICD, TELIGEN ICD (P960040/S360)Boston Scientific2015-12-21
BLAZER II XP, BLAZER PRIME XP AND INTELLA TIP MIFI XP (P020025/S081)Boston Scientific2015-12-17
DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S359)Boston Scientific2015-12-07
ORIGEN EL, INOGEN EL, DYNAGEN EL ICD'S ; ORIGEN MINI, INOGEN MINI, DYNAGEN MINI ICD'S (P960040/S358)Boston Scientific2015-11-19
ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS (P910073/S122)Boston Scientific2015-11-06
PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S357)Boston Scientific2015-10-21
ORIGEN EL ICD & MINI ICD, INOGEN EL ICD & MINI ICD; DYNAGEN EL ICD & MINI ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S356)Boston Scientific2015-10-19
FINELINE II STEROX IMPLANTABLE CARDIAC ENDOCARDIAL PACING LEADS (P960004/S074)Boston Scientific2015-10-13
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S080)Boston Scientific2015-10-13
FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD (P960004/S059)Boston Scientific2015-10-08
INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S355)Boston Scientific2015-10-07
DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD (P960040/S354)Boston Scientific2015-10-02
BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S079)Boston Scientific2015-10-01
FINELINE II STEROX ENDOCARDIAL PACING LOEADS & FINELINE II STEROX EZ ENDOCARDIAL PACING LEADS (P960004/S073)Boston Scientific2015-09-23
TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN EL. DYNAGEN MINI, INOGEN EL, INOGEN MINI, ORIGEN EL, ORIGEN MINI ICD'S (P960040/S351)Boston Scientific2015-09-17
EPT-1000XP CARDIAC ABLATION SYSTEM (P020025/S078)Boston Scientific2015-09-15
ORIGEN EL ICD, MINI ICD, DYNAGEN EL ICD, MINI ICD, INOGEN EL ICD, MINI ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD (P960040/S353)Boston Scientific2015-08-21
INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S075)Boston Scientific2015-08-19
FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS (P960004/S072)Boston Scientific2015-08-18
INCEPTA, ENERGEN,PUNCTUA, DYNAGEN, INOGEN, ORIGEN ICD'S (P960040/S352)Boston Scientific2015-08-08
DYNAGEN, INOGEN, ORIGEN ICD DEVICES (P960040/S350)Boston Scientific2015-07-31
TELIGEN,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN ICDS (P960040/S345)Boston Scientific2015-07-21
LATITUDE NXT PATIENT MANAGEMENT SYSTEM (P910077/S149)Boston Scientific2015-07-21
LATITUDE INDUCTIVE COMMUNICATOR ; LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM) (P910077/S150)Boston Scientific2015-07-20
ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS (P910073/S130)Boston Scientific2015-07-16
FINELINE 2 PACING LEADS (P960004/S070)Boston Scientific2015-07-16
FLEXTEND PACING LEADS (P960006/S044)Boston Scientific2015-07-16
FINELINE II STEROX ENDOCARDIAL PACING LEAD (P960004/S069)Boston Scientific2015-06-30
INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S074)Boston Scientific2015-06-23
DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CRT-D (P960040/S347)Boston Scientific2015-06-22
INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S072)Boston Scientific2015-06-12
ORIGEN EL ICD, ORIGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, INCEPTA ICD, ENERGEN I (P960040/S346)Boston Scientific2015-06-04
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S071)Boston Scientific2015-05-28
FINELINE II PACE/SENSE LEAD (P960004/S068)Boston Scientific2015-05-14
BLAZER PRIME XP, BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S070)Boston Scientific2015-05-11
BLAZER II XP, BLAZER PRIME XP, INTELLATIP MIFI XP SYSTEM CABLES (P020025/S069)Boston Scientific2015-04-23
BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S067)Boston Scientific2015-04-06
INOGEN, ORIGEN AND DYNAGEN ICD'S (P960040/S344)Boston Scientific2015-04-02
BLAZER II XP ABLATION CATHETERS, INTELLATIP MIFI XP ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES ASSOICATED WITH CARDIAC (P020025/S068)Boston Scientific2015-03-24
ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, ENDOTAK RELIANCE 4-SITE LEAD FAMILY (P910073/S129)Boston Scientific2015-03-19
INOGEN, ORIGEN AND DYNAGEN ICDS (P960040/S343)Boston Scientific2015-03-01
DYNAGEN, INOGEN, ORIGEBN, PUNCTUA,ENERGEN, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S342)Boston Scientific2015-02-23
NG3 FAMILY OF ICD'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF ICD'S (INCEPTA, ENERGEN, & PUNCTUA) (P960040/S336)Boston Scientific2015-01-29
INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S066)Boston Scientific2015-01-15
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