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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.
 
DeviceCGuard™ Prime Carotid Stent System
Generic NameStent, carotid
ApplicantInspireMD, Ltd.
6303 Waterford District Dr.
Suite 215
Miami, FL 33126
PMA NumberP240029
Supplement NumberS001
Date Received01/21/2026
Decision Date02/20/2026
Product Code NIM 
Advisory Committee Cardiovascular
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  
modification of the routine sterilization load
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