Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Valiant Navion Thoracic Stent Graft System
• Generic Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Applicant: Medtronic Vascular; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P100040
• Supplement Number: S041
• Date Received: 09/04/2020
• Decision Date: 10/05/2020
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for site change for packaging and labeling rework processes.