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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 NumberS003
Date Received02/10/2025
Decision Date03/11/2025
Product Codes PNF QWC 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for quality controls in the manufacturing process that add a minimum fillet size specification and a maximum length specification to provide additional assurance of strength and reliability of the Minima Stent System.
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