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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.
 
DeviceProtege RX Carotid Stent System
Generic NameStent, carotid
ApplicantMedtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441
PMA NumberP060001
Supplement NumberS033
Date Received03/29/2022
Decision Date05/23/2022
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for increasing the tolerance of the delivery system component.
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