FDA.reportPublic FDA data

NA

Primary DI
00802526527432
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
4603
Device description
Suture Sleeves
Published
2016-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWPImplantable pulse generator, pacemaker (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010012398
P010012453
P010012484

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010012398CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLBoston Scientific Corp2002-05-02NIK
P010012453CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLBoston Scientific Corp2002-05-02NIK
P010012484CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLBoston Scientific Corp2002-05-02NIK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526527432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526527432008025265274328025265274320802526527432

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead suture sleeveA small, sterile device with a hollow centre that functions as a channel for a pacing or defibrillation lead(s), and is positioned at the point where the surgeon will suture the lead to the patient's tissue to prevent it from moving after the implantation procedure is completed. It is typically made of a silicone rubber material and is implanted with the pacemaker or defibrillator system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055507Zenex MRI™ST. JUDE MEDICAL, INC.LWP2026-01-22
05415067055514Zenex MRI™ST. JUDE MEDICAL, INC.LWP2026-01-22
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWP2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWP2024-11-13
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
20763000181110NAMEDTRONIC, INC.LWP2024-08-30
20763000181134NAMEDTRONIC, INC.LWP2024-08-30
05415067040404NAST. JUDE MEDICAL, INC.LWP2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
00763000181208NAMEDTRONIC, INC.LWP2021-05-22
00763000181215NAMEDTRONIC, INC.LWP2021-05-14
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2021-02-25
00763000316693Azure™ S DR MRI SureScan™MEDTRONIC, INC.LWP2021-01-08
00763000316716Azure™ S SR MRI SureScan™MEDTRONIC, INC.LWP2021-01-08
00763000316846Azure™ XT DR MRI SureScan™MEDTRONIC, INC.LWP2021-01-08
00763000316723Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316730Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316747Adapta™ SMEDTRONIC, INC.LWP2020-11-28
00763000316761Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316778Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316785Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316792Adapta™MEDTRONIC, INC.LWP2020-11-28