Valiant Navion™

Basic Information

• Brand Name: Valiant Navion™
• Primary DI: 00763000260958
• Version / Model: VNMC4646C55TU
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-26
• Public Version: 4
• Public Version Date: 2023-08-04
• Public Version Status: Update
• Public Device Record Key: fd17fe3d-f5b0-4ccc-8fde-a94e84408cbc
• Distribution End Date: 2022-12-02

Device Description

STENT GRAFT VNMC4646C55TU VAL NAV CS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIH	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
48060	Descending thoracic aorta endovascular stent-graft	A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000260958	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P100040	036
P100040	041

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Stent Graft Length (Covered) 55 MM
Device Size Text, specify			Stent Graft Proximal Diameter 46 MM
Device Size Text, specify			Stent Graft Distal Diameter 46 MM

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the system at room temperature in a dark, dry place.