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: ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
• Generic Name: STENT, ILIAC
• Applicant: Medtronic, Ireland; Parkmore Business Park W.; Galway
• PMA Number: P110011
• Supplement Number: S012
• Date Received: 07/13/2016
• Decision Date: 08/10/2016
• Withdrawal Date: 01/22/2020
• 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  
Implement an electronic laboratory management system.