FDA.reportPublic FDA data

Durata®

Primary DI
05414734505123
Brand
Durata®
Company
ST. JUDE MEDICAL, INC.
Model
7131-65
Catalog number
7131-65
Device description
Defibrillation Lead
Published
2017-01-25
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)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950022049

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950022049TVL(TM) LEAD SYSTEMABBOTT MEDICAL1996-05-10LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734505123PrimaryGS10
H7587131650SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734505123054147345051235414734505123

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
Length65Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00
Special Storage Condition, Specify00Yes
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit

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
Expiration date on label
true

Other Devices From This Company#

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05415067026194EnSite™H702500H7025002016-12-08
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05415067052780Epic™EELT-27MEELT-27M2026-07-08
05415067052797Epic™ESP300-25ESP300-252026-07-08
05415067052803Epic™ESP300-19ESP300-192026-07-08
05415067052810Epic™EELT-19AEELT-19A2026-07-08
05415067052827Epic™EELT-29MEELT-29M2026-07-08
05415067052834Epic™EELT-27AEELT-27A2026-07-08
05415067052858Epic™EELT-25AEELT-25A2026-07-08
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