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 MUSCULAR VSD OCCLUDER
• Generic Name: Transcatheter septal occluder
• Applicant: ABBOTT MEDICAL; 177 County Rd. B E.; St. Paul, MN 55117
• PMA Number: P040040
• Supplement Number: S018
• Date Received: 03/09/2011
• Decision Date: 04/08/2011
• Product Code: MLV
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
MODIFICATIONS TO POUCH SEALING EQUIPMENT.