FDA.reportPublic FDA data

NA

Primary DI
00802526600609
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
3203
Device description
S-ICD Wand for 3200 Programmer and 3300 Programmer
Published
2019-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110042043
P110042083

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110042043SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042083SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526600609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526600609008025266006098025266006090802526600609

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator programmerAn external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106295384
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04035479182793Rivacor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182830Acticor Sky VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182847Acticor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183011Rivacor Aura VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183059Rivacor Rise VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183066Rivacor Rise VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479185695Rivacor Aura VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWS2025-06-25
05414734500586NAST. JUDE MEDICAL, INC.LWS2025-05-07
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWS2024-11-13
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.LWS2024-11-04
00763000180027Sprint Quattro Secure S™MEDTRONIC, INC.LWS2024-11-04
00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.LWS2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.LWS2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.LWS2024-11-04
00802526623400NABOSTON SCIENTIFIC CORPORATIONLWS2024-08-29
05415067049414Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049421Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049469Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049476Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
00763000369736Epsila EV™MEDTRONIC, INC.LWS2023-11-03
00763000369743Epsila EV™MEDTRONIC, INC.LWS2023-11-03
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