FDA.reportPublic FDA data

NA

Primary DI
00802526489532
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
6773
Device description
Suture Sleeves attachable
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010012009
P010012295
P010012352
P010012422

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010012009CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLBoston Scientific Corp2002-05-02NIK
P010012295CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLBoston Scientific Corp2002-05-02NIK
P010012352CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLBoston Scientific Corp2002-05-02NIK
P010012422CONTAK 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
00802526489532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526489532008025264895328025264895320802526489532

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
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04035479182816Acticor Sky HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182854Rivacor Sky HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182861Rivacor Sky HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182984Rivacor Aura HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182991Rivacor Aura HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479183028Rivacor Rise HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479183035Rivacor Rise HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
05414734509138NAST. JUDE MEDICAL, INC.NIK2026-03-04
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05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NIK2024-11-13
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05415067049520Gallant™ST. JUDE MEDICAL, INC.NIK2024-04-25
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05415067032829myMerlinPulse™ST. JUDE MEDICAL, INC.NIK2021-01-07
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