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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.
 
DeviceMinima Stent System; Minima Pro Stent System
Generic NameAortic stent
ApplicantRenata Medical, Inc.
4695 Macarthur Ct.
Suite 440
Newport Beach, CA 92660
PMA NumberP240003
Supplement NumberS008
Date Received07/16/2026
Decision Date08/27/2026
Product Codes PNF QWC 
Advisory Committee Cardiovascular
Clinical TrialsNCT05086016
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240003.
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