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: MULTI-LINK VISION MULTI-LINK MINI-VISION AND MULTI-LINK 8
• Generic Name: STENT, CORONARY
• Applicant: Abbott Vascular; P.O. Box 9018; Temecula, CA 92589
• PMA Number: P020047
• Supplement Number: S063
• Date Received: 09/25/2015
• Decision Date: 10/22/2015
• Product Code: MAF
• 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  
CHANGE TO THE STENT PROCESS MONITORING SYSTEM.