FDA.reportPublic FDA data

NA

Primary DI
00802526066719
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
6804
Device description
Lead Pulling Tip STL IS-1/DF-1
Published
2014-09-24
Public version status
Update
Distribution status
Not 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
P910073036

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910073036ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526066719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526066719008025260667198025260667190802526066719

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead tunnellerA sterile hand-held manual surgical instrument designed to create a tunnel (an artificial passageway) through subcutaneous tissue for the placement of an implantable extracardiac lead/electrode. It is a long, thin, semi-flexible rod with a rounded distal tip and a handle at the proximal end to allow the surgeon to push through body tissues; it may include an integrated sheath (e.g., split sheath) intended to assist lead placement. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
106295384
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729270133Polaris X™M0047000D0M0047000D02016-09-24
08714729270140Polaris X™M0047001D0M0047001D02016-09-24
08714729270164Polaris X™M0047003D0M0047003D02016-09-24
08714729270171Polaris X™M0047004D0M0047004D02016-09-24
08714729270188Polaris X™M0047005D0M0047005D02016-09-24
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24

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Primary DI, Brand, Company table
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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
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05415067050120Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWS2024-11-13
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05415067049414Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049421Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049469Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
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