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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.
 
DeviceProtégé RX Carotid Stent System; Protégé GPS Self-Expanding Peripheral Stent System
Generic NameStent, carotid
ApplicantMedtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441
PMA NumberP060001
Supplement NumberS046
Date Received03/04/2025
Decision Date03/07/2025
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  
approval of an additional nitinol gun-drilling process supplier
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