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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 NumberS005
Date Received09/30/2025
Decision Date12/18/2025
Product Codes PNF QWC 
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 the dimensional inspection of the Minima Stent from a receiving step at the system assembly contract manufacturer, Medical Murray, to an outgoing inspection at the Minima Stent Manufacturer, Meko Laser
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