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 EXPANDABLE STENT SYSTEM
• Generic Name: STENT, ILIAC
• Applicant: ABBOTT VASCULAR-CARDIAC THERAPIES; 3200 LAKESIDE DR.; SANTA CLARA, CA 95054-2807
• PMA Number: P110043
• Supplement Number: S002
• Date Received: 08/27/2012
• Decision Date: 09/24/2012
• Product Code: NIO
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00844532
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CHANGES TO THE EXTRUDED TUBING PROCESS.