FDA.reportPublic FDA data

SelectSecure™

Primary DI
00613994119957
Brand
SelectSecure™
Company
MEDTRONIC, INC.
Model
383074
Device description
LEAD,383074,BIP,CATH DELIV,4FR,74CM,EN
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
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
P030036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030036000MEDTRONIC SELECTSECURE LEAD MODEL 3830Medtronic Cardiac Rhythm Disease Management2005-08-03NVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994119957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994119957006139941199576139941199570613994119957

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial 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 pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. 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
Length74Centimeter

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
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
00643169014244INPUT™ PS5833112017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04035479177058Solia CSP S 53BIOTRONIK SE & Co. KGNVN2026-02-17
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00802526604430INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00802526604522INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00802526604577INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
04035479106232SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106249SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106256SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479106263SielloBIOTRONIK SE & Co. KGNVN2018-08-30
04035479118280SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479118297SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479132606SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
04035479136567SoliaBIOTRONIK SE & Co. KGNVN2018-08-30
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
04035479157821EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-22
04035479157838EFH-6F-WBIOTRONIK SE & Co. KGDTB2017-11-17
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.DTB2017-10-26
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.NVN2017-10-26
00643169410916CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-02-05