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: Amplatzer Septal Occluder
• Generic Name: Transcatheter septal occluder
• Applicant: ABBOTT MEDICAL; 177 County Rd. B E.; St. Paul, MN 55117
• PMA Number: P000039
• Supplement Number: S075
• Date Received: 08/24/2021
• Decision Date: 09/22/2021
• Product Code: MLV
• 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  
Addition of a sterilization chamber (Chamber 5) at the Steris sterilization facility in Costa Rica.