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: FlexNav Delivery System; Navitor Transcatheter Aortic Valves
• Generic Name: Aortic valve, prosthesis, percutaneously delivered
• Applicant: ABBOTT MEDICAL; 177 County Rd. B E.; St. Paul, MN 55117
• PMA Number: P190023
• Supplement Number: S028
• Date Received: 09/18/2025
• Decision Date: 10/15/2025
• Product Code: NPT
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
a change to the endotoxin extraction sample preparation method and to add the PyroGene endotoxin test method to detect bacterial endotoxins