FDA.reportPublic FDA data

ATTAIN STARFIX™

Primary DI
00643169590632
Brand
ATTAIN STARFIX™
Company
MEDTRONIC, INC.
Model
419578
Device description
LEAD 419578 ATTAIN US DEPLOYABLE OTW
Published
2016-01-14
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
OJXDrug eluting permanent left ventricular (lv) pacemaker electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3
OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060039061
P060039083

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060039061ATTAIN STARFIX MODEL 4195 LEADMedtronic, Inc.2008-06-13OJX
P060039083ATTAIN STARFIX MODEL 4195 LEADMedtronic, Inc.2008-06-13OJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169590632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169590632006431695906326431695906320643169590632

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
Length78Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature77 Degrees Fahrenheit77 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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00199150083817NABB10Z66R152026-05-30
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00199150080694NABB12V43R12026-05-23

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