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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.
 
DeviceNeuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection
Generic NameStent, carotid
ApplicantContego Medical, Inc.
3801 Lake Boone Trl.
Suite 100
Raleigh, NC 27607
PMA NumberP240009
Supplement NumberS012
Date Received06/30/2026
Decision Date07/29/2026
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  
to move an in-line leak inspection to a later step in the manufacturing process flow
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