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: Omnilink Elite™ Vascular Balloon-Exoandable Stent System
• Generic Name: STENT, ILIAC
• Applicant: Abbott Vascular-Cardiac Therapies; 3200 Lakeside Dr.; Santa Clara, CA 95054
• PMA Number: P110043
• Supplement Number: S013
• Date Received: 08/09/2022
• Decision Date: 09/07/2022
• Product Code: NIO
• 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 secondary sterilization equipment.