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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 Evolve Flow Diverter System
Generic NameIntracranial aneurysm flow diverter
ApplicantStryker Neurovascular
47900 Bayside Pkwy.
Fremont, CA 94538
PMA NumberP170024
Supplement NumberS011
Date Received11/09/2021
Decision Date11/30/2021
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  
Change in the coating lubricity testing from using work-in-progress test articles to core wire only test articles.
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