FDA.reportPublic FDA data

RELIANCE 4-FRONT™

Primary DI
00802526592850
Brand
RELIANCE 4-FRONT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
0662
Device description
Integrated Bipolar Pace/Sense and Defibrillation Lead
Published
2018-08-25
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
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P910073145
P910073153
P910073165
P910073179
P910073185
P910073187

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910073145ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073153ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073165ENDOTAK LEAD SYSTEMBoston Scientific1993-08-26LWS
P910073179ENDOTAK 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
00802526592850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526592850008025265928508025265928500802526592850

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
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28
08714729860501WATCHMAN FLX™M635WU50270M635WU502702020-07-28
08714729860518WATCHMAN FLX™M635WU50310M635WU503102020-07-28
08714729860525WATCHMAN FLX™M635WU50350M635WU503502020-07-28
00191506063146OPAL HDx™M004OPAL65110M004OPAL651102026-10-30
00191506063153OPAL HDx™M004OPAL63020M004OPAL630202026-10-30
00191506063191OPAL HDx™M004OPAL14010M004OPAL140102026-10-28
08714729840442SYNERGY™H7493926108220H74939261082202016-01-14
08714729840459SYNERGY™H7493926108250H74939261082502016-01-14
08714729840466SYNERGY™H7493926108270H74939261082702016-01-14
08714729840473SYNERGY™H7493926108300H74939261083002016-01-14
08714729840480SYNERGY™H7493926108350H74939261083502016-01-14
08714729840497SYNERGY™H7493926108400H74939261084002016-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180119Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180232Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180263Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180317Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180324Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180331Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000180348Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000369743Epsila EV™MEDTRONIC, INC.NVY2023-11-03
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000369767Epsila EV™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000571528NAMEDTRONIC, INC.NVY2023-07-30
00763000740269SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2022-12-11
00763000059385NAMEDTRONIC, INC.NVY2018-12-22
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2018-10-11
00763000130817SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2018-10-11
00802526496868RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526496967RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526496981RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526497001RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592805RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592829RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592867RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00763000014643CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-20