FDA.reportPublic FDA data

Sprint Quattro®

Primary DI
00643169335585
Brand
Sprint Quattro®
Company
MEDTRONIC, INC.
Model
6946M72
Device description
LEAD 6946M72 USA EN SPRINT DF4 PASSIVE
Published
2016-08-07
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
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
P920015155

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920015155MEDTRONIC(R) TRANSVENE LEAD SYSTEMMedtronic, Inc.1993-12-09NVY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169335585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169335585006431693355856431693355850643169335585

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
Length72Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature77 Degrees Fahrenheit77 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
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169988651Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-09-25
00643169720374Evera™ XT DRMEDTRONIC, INC.LWS2017-09-15
00643169720527Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-09-15
00643169720558Evera MRI™ XT VR SureScan®MEDTRONIC, INC.LWS2017-09-15
00643169720626Visia AF™ VRMEDTRONIC, INC.LWS2017-09-15
00643169720794Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169837829Visa AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-09-15
00643169858305Sprint Quattro™ MRI SureScan™MEDTRONIC, INC.LWS2017-06-11
00643169858329Sprint Quattro™ MRI SureScan™MEDTRONIC, INC.NVY2017-06-11
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVY2017-06-02
00643169633735CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633742CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633766CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633773CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169633780CapSureFix Novus MRI™ SureScan®MEDTRONIC, INC.NVY2017-06-02
00643169929258Evera MRI™ S DR SureScan™MEDTRONIC, INC.LWS2017-05-22
00643169929265Evera MRI™ S DR SureScan®MEDTRONIC, INC.LWS2017-05-22
00643169929944Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2017-05-22
00643169857674SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169857681SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169857698SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2017-05-21
00643169929197Evera MRI™ XT DR SureScan™MEDTRONIC, INC.LWS2017-05-14
00643169929760Visia AF™ VRMEDTRONIC, INC.LWS2017-05-14
00643169929913Visia AF MRI™ VR SureScan™MEDTRONIC, INC.LWS2017-05-12
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169708174CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2016-12-26