FDA.reportPublic FDA data

ENDOTAK RELIANCE® S

Primary DI
00802526531101
Brand
ENDOTAK RELIANCE® S
Company
BOSTON SCIENTIFIC CORPORATION
Model
0137
Catalog number
0137
Device description
Integrated Bipolar Pace/Sense and Defibrillation Lead
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
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
P910073115
P910073116
P910073122
P910073123
P910073133
P910073153
P910073155
P910073182
P910073185
P910073187

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910073115ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073116ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073122ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073123ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073133ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073153ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073155ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073182ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073185ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073187ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526531101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526531101008025265311018025265311010802526531101

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial defibrillation leadAn implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
106295384
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24

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Primary DI, Brand, Company table
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