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: COMPLETE SE VASCULAR STENT SYSTEM– ILIAC
• Generic Name: STENT, ILIAC
• Applicant: Medtronic Vascular; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P090006
• Supplement Number: S019
• Date Received: 08/17/2016
• Decision Date: 02/01/2017
• Withdrawal Date: 05/23/2019
• Product Code: NIO
• Advisory Committee: Cardiovascular
• Supplement Type: 135 Review Track For 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  
Approval for updated in-process sampling requirements and to remove redundant inspections.