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: Absolute Pro Vascular Self-Expanding Stent System.
• Generic Name: STENT, ILIAC
• Applicant: Abbott Vascular, Inc.; 3200 Lakeside Dr.; Santa Clara, CA 92054
• PMA Number: P110028
• Supplement Number: S017
• Date Received: 03/16/2017
• Decision Date: 04/14/2017
• 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 new equipment for stent laser cutting operations and modifications to associated manufacturing processes.