FDA.reportPublic FDA data

Endeavor® sprint

Primary DI
00613994539311
Brand
Endeavor® sprint
Company
MEDTRONIC, INC.
Model
ENSP35009W
Device description
STENT ENSP35009WENDEAVORSPRINT3.50X09OTW
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIQCoronary drug-eluting stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIQCoronary Drug-Eluting StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060033001

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994539311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994539311006139945393116139945393110613994539311

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length9Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in original container
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994963826NIH™0087612016-07-24
00613994964274NIH™ Cardio-Marker0100112016-06-10
00613994964540Lehman™0012592016-06-05
00613994964564Lehman™0012632016-06-05
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00681490860659DLPCB140172016-05-22
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290107017930EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017947EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017954EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017961EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017978EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017985EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017992EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107018005EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
08717648231261XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231278XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231285XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231308XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231315XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
07290107015202EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015219EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015226EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015233EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015240EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015257EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015264EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015271EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015288EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015295EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015301EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015318EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015325EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015332EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015349EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015356EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015363EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10