FDA.reportPublic FDA data

Durata™

Primary DI
05414734503167
Brand
Durata™
Company
ST. JUDE MEDICAL, INC.
Model
7121Q-58
Catalog number
7121Q-58
Device description
Defibrillation Lead
Published
2017-04-10
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
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950022042
P950022110
P950022119

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950022042TVL(TM) LEAD SYSTEMABBOTT MEDICAL1996-05-10LWS
P950022110TVL(TM) LEAD SYSTEMABBOTT MEDICAL1996-05-10LWS
P950022119TVL(TM) LEAD SYSTEMABBOTT MEDICAL1996-05-10LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734503167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734503167054147345031675414734503167

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
Length58Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22
05415067016683NA231623162015-09-08

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