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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSurpass Streamline Flow Diverter
Generic NameIntracranial aneurysm flow diverter
ApplicantStryker Neurovascular
47900 Bayside Pkwy.
Fremont, CA 94538
PMA NumberP170024
Supplement NumberS024
Date Received07/24/2025
Decision Date08/20/2025
Product Code OUT 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for manufacturing process improvements for the manufacturing line for the Surpass Evolve Flow Diverter System (FDS) and Surpass Elite Flow Diverter System, as well as Stent Loader equipment upgrades for Surpass Evolve FDS.
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