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: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Applicant: ABBOTT MEDICAL; 177 County Rd. B E.; St. Paul, MN 55117
• PMA Number: P000039
• Supplement Number: S051
• Date Received: 08/10/2015
• Decision Date: 01/08/2016
• Product Code: MAE
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE ADDITION OF INFORMATION FROM THE POST-APPROVAL STUDY TO THEINSTRUCTIONS FOR USE.