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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 Elite Flow Diverter System
Generic NameIntracranial aneurysm flow diverter
ApplicantStryker Neurovascular
47900 Bayside Pkwy.
Fremont, CA 94538
PMA NumberP170024
Supplement NumberS012
Date Received05/01/2023
Decision Date05/18/2024
Product Code OUT 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the Surpass Elite Flow Diverter System that was developed through design modifications to the approved Surpass Evolve Flow Diverter System (P170024/S003). The design modifications consist of changes to the delivery system resheath pad and distal protection assembly, the stent braid to include a 5.25 mm diameter stent model and picks per inch specifications to be the same for all stent diameters, and manufacturing process for the stent braid and delivery system.
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