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: ACS MULTI-LINK CORONARY STENT SYSTEM
• Generic Name: STENT, CORONARY
• Applicant: Abbott Vascular, Inc.; 26531 Ynez Rd.; Temecula, CA 92591
• PMA Number: P970020
• Supplement Number: S037
• Date Received: 10/12/2001
• Decision Date: 05/01/2002
• Withdrawal Date: 04/15/2025
• Product Code: MAF
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.