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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.
 
DeviceNeuroform Atlas Stent System
Generic NameIntracranial coil-assist stent
ApplicantStryker Neurovascular
47900 Bayside Pkwy.
Fremont, CA 94538
PMA NumberP180031
Supplement NumberS011
Date Received04/10/2025
Decision Date05/09/2025
Product Code QCA 
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  
to introduce a new degreaser solvent to use in the manufacture of the Radiopaque Marker Band
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