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: Surmodics SurVeil™ Drug-Coated Balloon
• Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: Surmodics,Inc.; 9924 W. 74th St.; Eden Prairie, MN 55344
• PMA Number: P210025
• Supplement Number: S001
• Date Received: 12/06/2023
• Decision Date: 01/03/2024
• Product Code: ONU
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
addition of a dose audit site.