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: Astron Peripheral Self- Expanding Nitinol Stent System
• Generic Name: STENT, ILIAC
• Applicant: Biotronik AG; Ackerstrasse 6; Bülach 8180
• PMA Number: P140030
• Supplement Number: S021
• Date Received: 10/20/2025
• Decision Date: 10/21/2025
• Product Code: NIO
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to add a control step to verify the carton packaging material