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: Surpass Streamline Flow Diverter
• Generic Name: Intracranial aneurysm flow diverter
• Applicant: Stryker Neurovascular; 47900 Bayside Pkwy.; Fremont, CA 94538
• PMA Number: P170024
• Supplement Number: S001
• Date Received: 09/20/2018
• Decision Date: 10/05/2018
• Product Code: OUT
• Advisory Committee: Neurology
• 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  
Reduction of the frequency of in-process inspection for the pouch sealing process to once daily.