AccessGUDID - DEVICE: Valiant Navion™ (00763000260804)

GUDID

Device Identifier (DI) Information

Brand Name: Valiant Navion™
Version or Model: VNMC3434C90TU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000260804
Issuing Agency: GS1
Commercial Distribution End Date: December 02, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: STENT GRAFT VNMC3434C90TU VAL NAV CS

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48060	Descending thoracic aorta/aortic isthmus endovascular stent-graft	A non-bioabsorbable tubular device intended to be percutaneously introduced for endovascular implantation primarily within the descending thoracic aorta and/or aortic isthmus to repair a lesion [e.g., thoracic aortic aneurysm (TAA), traumatic transections, dissections, fistulae, penetrating ulcers, coarctations]. It is in the form of a metallic mesh with a synthetic polymer tube (endovascular graft), and is designed as a continuous non-fenestrated tube. It may be used in singular and/or modular configurations; it does not include anticoagulants or pharmaceuticals. A disposable delivery device may be packaged with the stent-graft.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIH	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100040	036
P100040	041

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store the system at room temperature in a dark, dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Stent Graft Distal Diameter 34 MM
Device Size Text, specify: Stent Graft Length (Covered) 90 MM
Device Size Text, specify: Stent Graft Proximal Diameter 34 MM

Device Record Status

Public Device Record Key: bd5c4340-a573-4e1a-9e90-6c401d28fd8e
Public Version Date: September 23, 2026
Public Version Number: 6
DI Record Publish Date: April 26, 2020