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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 NumberS004
Date Received01/12/2022
Decision Date02/07/2022
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  
Three changes to the non-patient contacting introducer sheath component of the Neuroform Atlas Stent System: 1) sheath manufacturing to be outsourced to an external supplier; 2) change from a three- to two-step manufacturing process; and 3) tip length specification simplification and change of the nominal length.
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