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: Seprafilm Adhesion Barrier
• Generic Name: Barrier, absorbable, adhesion
• Applicant: Baxter Healthcare Corporation; One Baxter Pkwy.; Deerfield Lake, IL 60015
• PMA Number: P950034
• Supplement Number: S050
• Date Received: 02/08/2018
• Decision Date: 03/09/2018
• Product Code: MCN
• Advisory Committee: General & Plastic Surgery
• 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  
Implementation of a new casting machine.