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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
Generic NameAortic stent
ApplicantRenata Medical, Inc.
4695 Macarthur Ct.
Suite 440
Newport Beach, CA 92660
PMA NumberP240003
Supplement NumberS004
Date Received08/13/2025
Decision Date09/11/2025
Product Codes PNF QWC 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the Instructions for Use labeling, including additional precautions, intended to enhance the safe use of the Minima Stent System.
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