FDA.reportPublic FDA data

SPRINT QUATTRO®

Primary DI
00643169451452
Brand
SPRINT QUATTRO®
Company
MEDTRONIC, INC.
Model
6944-75
Device description
LEAD 6944-75 SPRINT QUATTRO US
Published
2015-02-16
Public version status
Update
Distribution status
Not 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
DTBpermanent pacemaker Electrode
DXYimplantable pacemaker Pulse-generator
LWSImplantable cardioverter defibrillator (non-CRT)
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920015138

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920015138MEDTRONIC(R) TRANSVENE LEAD SYSTEMMedtronic, Inc.1993-12-09NVY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169451452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169451452006431694514526431694514520643169451452

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial defibrillation leadA sterile, 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
Length75Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

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
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVY2017-06-02
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169410947CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169300842NAMEDTRONIC, INC.LWS2016-08-29
00643169335561Sprint Quattro®MEDTRONIC, INC.LWS2016-08-07
00643169335578Sprint Quattro®MEDTRONIC, INC.LWS2016-08-07
00643169335585Sprint Quattro®MEDTRONIC, INC.LWS2016-08-07
00643169335592Sprint Quattro®MEDTRONIC, INC.NVY2016-08-07
00643169451476SPRINT QUATTRO®MEDTRONIC, INC.DXY2016-07-31
00643169451476SPRINT QUATTRO®MEDTRONIC, INC.NVY2016-07-31
00643169451476SPRINT QUATTRO®MEDTRONIC, INC.LWS2016-07-31
00643169535930SPRINT QUATTRO SECURE S™ DXAC/DSPMEDTRONIC, INC.NVY2016-07-31
00643169356559Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2015-09-21
00643169356566Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2015-09-21
00643169356610Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2015-09-21
00643169356627Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2015-09-21
00643169535954SPRINT QUATTRO SECURE® DXAC/DSPMEDTRONIC, INC.DTB2015-07-10
00643169535978SPRINT QUATTRO SECURE® DXAC/DSPMEDTRONIC, INC.DTB2015-07-10
00643169535985TRANSVENE®-CS/SVCMEDTRONIC, INC.LWS2015-07-10
00643169535985TRANSVENE®-CS/SVCMEDTRONIC, INC.NVY2015-07-10