FDA.reportPublic FDA data

Endurant® II

Primary DI
00763000306274
Brand
Endurant® II
Company
MEDTRONIC, INC.
Model
ETLW1613C124E
Device description
STENT GRAFT ETLW1613C124E ENDUR II LIMB
Published
2020-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100021011
P100021077
P100021083

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100021011MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMedtronic Vascular2010-12-16MIH
P100021077MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMedtronic Vascular2010-12-16MIH
P100021083MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMedtronic Vascular2010-12-16MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000306274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000306274007630003062747630003062740763000306274

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal aorta endovascular stent-graftA sterile non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the system at room temperature in a dark, dry place.

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150062911N/AAFR-002132026-09-04
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002599819Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599840Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599871Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599901Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599932Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599963Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599994Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600027Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600058Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600089Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600119Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600140Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600171Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600201Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600232Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600263Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600294Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600324Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600355Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600393Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600409Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600430Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600461Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600492Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600522Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600553Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600584Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600614Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600645Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600676Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04