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: Neuroform Atlas® Stent System
• Generic Name: Intracranial coil-assist stent
• Applicant: Stryker Neurovascular; 47900 Bayside Pkwy.; Fremont, CA 94538
• PMA Number: P180031
• Supplement Number: S002
• Date Received: 08/21/2019
• Decision Date: 01/18/2020
• Product Code: QCA
• 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.