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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.
 
DeviceRoadsaver/CASPER Carotid Stent Device
Generic NameStent, carotid
ApplicantMicroVention, Inc.
1311 Valencia Ave.
Tistin, CA 92780
PMA NumberP210030
Supplement NumberS001
Date Received02/03/2025
Decision Date06/23/2025
Product Code NIM 
Advisory Committee Cardiovascular
Clinical TrialsNCT02657707
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for post-approval labeling update to include the CONFIDENCE study results through 3 years of follow-up
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