FDA.reportPublic FDA data

NA

Primary DI
00763000059385
Brand
NA
Company
MEDTRONIC, INC.
Model
6719
Device description
PIN PLUG 6719 CONNCTR PORT OUS US EIFU
Published
2018-12-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920015113

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920015113MEDTRONIC(R) TRANSVENE LEAD SYSTEMMedtronic, Inc.1993-12-09NVY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000059385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000059385007630000593857630000593850763000059385

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator port plugA device used to seal the unused connector port of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD), to provide electrical isolation and protect the parent device from the extremely hostile environment of the human body when implanted. It is typically made of high-grade stainless steel and silicone, and is inserted sterile into the vacant port (e.g., an IS-1 connection). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923617USB Flash Drive1560-2026-10-25
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02
00643169014237INPUT™ PS5933112017-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526623400NABOSTON SCIENTIFIC CORPORATIONLWS2024-08-29
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.LWS2023-11-02
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000060107Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2020-09-04
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
00802526592850RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00802526592867RELIANCE 4-FRONT™BOSTON SCIENTIFIC CORPORATIONNVY2018-08-25
00763000001513Primo MRI™ DR SureScan™MEDTRONIC, INC.LWS2018-06-02
00763000001551Primo MRI™ VR SureScan™MEDTRONIC, INC.LWS2018-06-02
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00763000059705Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-10-21
00763000059491Evera MRI™ XT DR SureScan®MEDTRONIC, INC.LWS2017-10-20
00763000059507Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-10-20
00763000059521Evera MRI™ XT DR SureScan®MEDTRONIC, INC.LWS2017-10-20
00763000059576Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-10-20
00802526599200EMBLEM™ S-ICDBOSTON SCIENTIFIC CORPORATIONLWS2017-10-12
00643169720466Evera™ XT VRMEDTRONIC, INC.LWS2017-09-15
00643169720497Evera MRI™ XT DR SureScan®MEDTRONIC, INC.LWS2017-09-15
00643169720794Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169837744Evera MRI™ S DR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169837799Visa AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVY2017-06-02
00643169633735CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633742CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02