FDA.report

Endeavor® sprint

Primary DI
00613994539618
Brand
Endeavor® sprint
Company
MEDTRONIC, INC.
Model
ENSP35024W
Device description
STENT ENSP35024WENDEAVORSPRINT3.50X24OTW
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NIQCoronary drug-eluting stent

Product Code Classifications

CodeDeviceSpecialtyClass
NIQCoronary Drug-Eluting StentUnknown3

Premarket Submissions

SubmissionSupplement
P060033001

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P060033001ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMMedtronic, Inc.2008-02-01NIQ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613994539618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994539618006139945396186139945396180613994539618

GMDN Terms

TermDefinition
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coatedA sterile non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length24Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in original container
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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