FDA.reportPublic FDA data

Capsure® EPI

Primary DI
00613994492340
Brand
Capsure® EPI
Company
MEDTRONIC, INC.
Model
4968-60
Device description
LEAD 4968-60 US BIPOLAR EPICARDIAL 60CM
Published
2014-09-23
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
DTBpermanent pacemaker Electrode
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950024017
P950024092

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950024017MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695Medtronic, Inc.1996-09-06NVN
P950024092MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695Medtronic, Inc.1996-09-06NVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994492340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994492340006139944923406139944923400613994492340

GMDN Terms#

Term, Definition table
TermDefinition
Epicardial pacing leadA sterile, implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pacemaker to the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is normally implanted in the outer surface of the heart (epicardium) in close contact to the wall of one of the chambers of the heart (endocardium), and the other end is connected to the pacemaker. It may be impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Centimeter

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

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00199150083893NA7E60R32026-05-30
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169453180CapSureFix™ NovusMEDTRONIC, INC.NVN2017-06-02
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.NVN2017-02-05
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00643169448858CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-02-05
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00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05
00643169448865CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-02-05
00643169335592Sprint Quattro®MEDTRONIC, INC.NVY2016-08-07
00643169451476SPRINT QUATTRO®MEDTRONIC, INC.NVY2016-07-31
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
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00643169535954SPRINT QUATTRO SECURE® DXAC/DSPMEDTRONIC, INC.DTB2015-07-10
00643169535978SPRINT QUATTRO SECURE® DXAC/DSPMEDTRONIC, INC.DTB2015-07-10
00643169535985TRANSVENE®-CS/SVCMEDTRONIC, INC.NVY2015-07-10
00643169535992TRANSVENE®-CS/SVCMEDTRONIC, INC.NVY2015-07-10
00643169536005TRANSVENE®-CS/SVCMEDTRONIC, INC.DTB2015-07-10