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: Pipeline Flex Embolization Device with Shield Technology
• Generic Name: Intracranial aneurysm flow diverter
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular; 9775 Toledo Way; Irvine, CA 92618
• PMA Number: P100018
• Supplement Number: S032
• Date Received: 04/30/2021
• Decision Date: 07/19/2021
• Product Code: OUT
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol..