FDA.reportPublic FDA data

NA

Primary DI
00681490124225
Brand
NA
Company
MEDTRONIC, INC.
Model
5071-15
Device description
LEAD 5071-15 PACING EPI SCREW-IN US
Published
2014-09-23
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031274000MODEL 5071 MYOCARDIAL PACING LEADMedtronic Vascular2003-05-22DTB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681490124225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490124225006814901242256814901242250681490124225

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
Length15Centimeter

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000180027Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180034Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180119Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180126Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180133Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180140Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180157Sprint Quattro Secure S™MEDTRONIC, INC.DTB2024-11-04
00763000180232Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000180249Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180263Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180317Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180324Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.DTB2024-11-04
00763000180331Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000180355Sprint Quattro Secure™MEDTRONIC, INC.DTB2024-11-04
00763000740252SelectSecure™ MRI SureScan™MEDTRONIC, INC.DTB2022-12-11
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00763000059477NAMEDTRONIC, INC.DTB2018-12-28
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00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26