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Boston Scientific

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

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RecordFirmDate
ESSENTIO™ MRI (Models L110, L111, L131) PROPONENT™ MRI (Models L210, L211, L231) ACCOLADE™ MRI (Models L310, L311, L331) (P150012/S173)Boston Scientific2025-12-19
ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331) (P150012/S175)Boston Scientific2025-12-17
FINELINE II Leads (P960004/S109)Boston Scientific2025-10-24
ENDOTAK RELIANCE Leads (P910073/S182)Boston Scientific2025-10-24
L110 ESSENTIO™ MRI SR,L111 ESSENTIO™ MRI DR,L131 ESSENTIO™ MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A (P150012/S172)Boston Scientific2025-10-22
D010 INOGEN™ MINI ICD VR, D011 INOGEN™ MINI ICD VR, D012 INOGEN™ MINI ICD DR, D013 INOGEN™ MINI ICD DR, D020 DYNAGEN™ MI (P960040/S510)Boston Scientific2025-10-22
D010 INOGEN™ MINI ICD VR,D011 INOGEN™ MINI ICD VR,D012 INOGEN™ MINI ICD DR,D013 INOGEN™ MINI ICD DR,D020 DYNAGEN™ MINI I (P960040/S511)Boston Scientific2025-10-22
RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™) (P020025/S147)Boston Scientific2025-10-17
Accolade MRI Pacemakers, ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI ( (P150012/S170)Boston Scientific2025-09-22
Implantable Cardioverter Defibrillator, INOGEN (Models D010, D011, D012, D013, D140, D141, D142, D143); DYNAGEN (Models (P960040/S508)Boston Scientific2025-09-22
ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM (P960004/S110)Boston Scientific2025-09-16
ACC SUP FIXATION TOOL (P960006/S057)Boston Scientific2025-09-16
ACC SUP VEIN PICK (P830060/S091)Boston Scientific2025-09-16
ACC WRENCH (P930035/S035)Boston Scientific2025-09-16
ACC SUP PLUG (P910077/S196)Boston Scientific2025-09-16
ACC STY TPR 0.013 - Accessory Stylet Straight, X-Soft; ACC STY 0.014 SOFT LONG TPR - Accessory Stylet Long Taper, Soft; (P150012/S171)Boston Scientific2025-09-16
ACC SUP CONNECTOR QUAD PSA TO IS4; ACC SUP SUTURE SLEEVE; ACC SUP KIT LD CAP; STRL PKG LEAD REPAIR KIT; ACC STY STR .016 (P910073/S183)Boston Scientific2025-09-16
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S509)Boston Scientific2025-09-16
FINELINE® II EZ Sterox (P960004/S106)Boston Scientific2025-08-22
INGEVITY™ MRI, INGEVITY™ + (P150012/S153)Boston Scientific2025-08-22
ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™ (P910073/S176)Boston Scientific2025-08-22
THINLINE ENDOCARDIAL PACING LEADS (P960004/S108)Boston Scientific2025-08-19
Blazer™ II XP Cardiac Ablation Catheter and Cable (P020025/S146)Boston Scientific2025-08-14
Stylets Models 6053, 6054, 6055 (P960004/S107)Boston Scientific2025-07-28
ESSENTIO™ MRI (Models L110, L111, L131); PROPONENT™ MRI (Models L210, L211, L231); ACCOLADE™ MRI (Models L310, L311, L33 (P150012/S168)Boston Scientific2025-07-11
Endotak Lead System (P910073/S181)Boston Scientific2025-06-04
INGEVITY+ Active Fixation (P150012/S167)Boston Scientific2025-04-16
Essentio MRI SR; Essentio MRI DR; L131 Essentio MRI EL DR; Proponent; Accolade MRI SR; Accolade MRI DR; Accolade MRI EL (P150012/S166)Boston Scientific2025-04-11
D010 INOGEN™ MINI ICD VR; D011 INOGEN™ MINI ICD VR; D012 INOGEN™ MINI ICD DR; D013 INOGEN™ MINI ICD DR; D020 DYNAGEN™ MI (P960040/S504)Boston Scientific2025-04-11
RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™) (P020025/S145)Boston Scientific2025-03-31
IntellaNav MiFi XP Ablation Catheter (P020025/S144)Boston Scientific2025-03-20
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S164)Boston Scientific2024-12-18
RELIANCE 4-FRONT™ (P910073/S179)Boston Scientific2024-12-03
D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MINI IC (P960040/S503)Boston Scientific2024-11-25
L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, L31 (P150012/S163)Boston Scientific2024-11-25
INGEVITY+ (P150012/S162)Boston Scientific2024-11-08
LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC, (P910073/S180)Boston Scientific2024-11-07
ACCOLADE (P150012/S160)Boston Scientific2024-11-01
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S161)Boston Scientific2024-10-23
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S502)Boston Scientific2024-10-23
INGEVITY + Leads - Active Fixation (P150012/S158)Boston Scientific2024-09-16
Latitude™ NXT Patient Management System (P910077/S194)Boston Scientific2024-07-18
Latitude™ NXT Patient Management System (INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S157)Boston Scientific2024-07-18
Latitude™ NXT Patient Management System (TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, (P960040/S500)Boston Scientific2024-07-18
INTELLAGEN™ Cardiac Ablation System (P020025/S141)Boston Scientific2024-07-17
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S156)Boston Scientific2024-06-04
L110 ESSENTIO™ MRI SR, L111 ESSENTIO™ MRI DR, L131 ESSENTIO™ MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, (P150012/S159)Boston Scientific2024-05-29
D010 INOGEN™ MINI ICD VR, D011 INOGEN™ MINI ICD VR, D012 INOGEN™ MINI ICD DR, D013 INOGEN™ MINI ICD DR, D020 DYNAGEN™ MI (P960040/S501)Boston Scientific2024-05-29
RELIANCE 4-FRONT (P910073/S178)Boston Scientific2024-05-22
LATITUDE™ Programming System (P910077/S193)Boston Scientific2024-04-30
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S499)Boston Scientific2024-04-30
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S155)Boston Scientific2024-04-30
BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLAZER™ Solid-Tip Ablation Catheter Cable 3’, INTELLATIP MIFI™ XP Cable, (P020025/S139)Boston Scientific2024-04-05
Lead Repair Kit Model 6946 (P910073/S177)Boston Scientific2024-03-28
IntellaNav™ XP and IntellaNav MiFi™ XP Ablation Catheters (P020025/S143)Boston Scientific2024-02-16
Lead Repair Kit Model 6946 (P910073/S175)Boston Scientific2024-01-19
Medical Adhesive Model 6517 (P830060/S090)Boston Scientific2024-01-19
Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent MRI SR, Proponent MRI DR, Accolade MRI SR, Accoldae MRI (P150012/S154)Boston Scientific2023-12-29
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S142)Boston Scientific2023-12-12
INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI ICD DR, MOMENTUM™ EL ICD VR, MOMENTUM™ EL (P960040/S498)Boston Scientific2023-11-21
HeartLogic™ (P960040/S493)Boston Scientific2023-11-15
Lead Repair Kit Model 6946 (P910073/S174)Boston Scientific2023-10-24
ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI EL DR, PROPONENT, ACCOLADE™ MRI SR, ACCOLADE™ MRI DR, ACCOLADE™ MRI EL (P150012/S152)Boston Scientific2023-10-18
INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI ICD DR, MOMENTUM™ EL ICD VR, MOMENTUM™ EL (P960040/S497)Boston Scientific2023-10-18
INGEVITY™ and INGEVITY+TM active leads (P150012/S150)Boston Scientific2023-10-13
PG ACCOLADE MRI SR SL US, PG ACCOLADE MRI DR SL US, PG ACCOLADE MRI DR EL US, PG PROPONENT MRI SR SL US, PG PROPONENT MR (P150012/S151)Boston Scientific2023-10-06
LD Ingevity Plus AF IS1 (P150012/S149)Boston Scientific2023-09-08
ID/SN Label (P960004/S104)Boston Scientific2023-08-03
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S140)Boston Scientific2023-07-27
Accessory, Cap, Accessory, Plug (P910077/S192)Boston Scientific2023-07-21
FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US (P960004/S105)Boston Scientific2023-07-21
ORIGEN™ MINI ICD VR, ORIGEN™ MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI (P960040/S496)Boston Scientific2023-07-21
Accessory, Wrench (P930035/S034)Boston Scientific2023-07-21
Lead Repair Kit, ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™, A (P910073/S173)Boston Scientific2023-07-21
Accessory, Stabilizer (P960006/S056)Boston Scientific2023-07-21
ACUITY Stylet, Straight 0.013, 45cm, ACUITY Stylet, Straight 0.013, 52cm, ACUITY Stylet, Straight 0.013, 59cm, ACUITY St (P150012/S148)Boston Scientific2023-07-21
Accessory, Cap, Accessory, Sleeve, Accessory, Wrench Torque BI (P830060/S089)Boston Scientific2023-07-21
ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR (P960040/S495)Boston Scientific2023-07-20
Implantable Cardioverter Defibrillators (ICDs) (P960040/S494)Boston Scientific2023-07-07
FINELINE® II Sterox, FINELINE® II EZ Sterox (P960004/S103)Boston Scientific2023-07-06
ENDOTAK RELIANCE®, RELIANCE 4-FRONT™ (P910073/S172)Boston Scientific2023-07-06
INGEVITY™ MRI, INGEVITY™+ (P150012/S147)Boston Scientific2023-07-06
INGEVITY™ MRI Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead, INGEVITY™+ Pace/Sense Lead (P150012/S146)Boston Scientific2023-06-29
FINELINE®II EZ Sterox Bipolar IS-1 Atrial/Ventricular, J shaped Lead Stylets Limber, J shaped Lead Stylets Firm, J shape (P960004/S102)Boston Scientific2023-06-29
INGEVITY+ and INGEVITY MRI Pace/Sense leads (P150012/S145)Boston Scientific2023-05-17
Accolade MRI Pacemakers (P150012/S142)Boston Scientific2023-05-11
NG3 Implantable Cardioverter Defibrillators (ICDs), NG4 ICDs (P960040/S491)Boston Scientific2023-05-11
ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI EL DR, PROPONENT, ACCOLADE™ MRI SR, ACCOLADE™ MRI DR, ACCOLADE™ MRI EL (P150012/S144)Boston Scientific2023-05-08
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P960040/S492)Boston Scientific2023-05-01
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P150012/S143)Boston Scientific2023-05-01
Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I (P020025/S138)Boston Scientific2023-04-27
LATITUDE™ NXT Release 7.3 (P910077/S191)Boston Scientific2023-04-21
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S140)Boston Scientific2023-04-21
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S490)Boston Scientific2023-04-21
INGEVITY MRI, INGEVITY+ (P150012/S139)Boston Scientific2023-04-19
INGEVITY and INGEVITY+ (P150012/S141)Boston Scientific2023-03-01
RELIANCE 4-FRONT (P910073/S171)Boston Scientific2023-01-16
ICD Devices (P960040/S483)Boston Scientific2022-12-20
PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S138)Boston Scientific2022-12-20
ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR (P960040/S489)Boston Scientific2022-12-20
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