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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 Pro Stent System
Generic NameAortic stent
ApplicantRenata Medical, Inc.
4695 Macarthur Ct.
Suite 440
Newport Beach, CA 92660
PMA NumberP240003
Supplement NumberS006
Date Received12/23/2025
Decision Date07/09/2026
Product Codes PNF QWC 
Advisory Committee Cardiovascular
Clinical TrialsNCT05086016
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for design modifications and a line extension to the Minima Stent System, including a stent design change from closed cell to hybrid open-cell, a new 10mm balloon size for expansion of the stent, delivery system design changes, and packaging design changes. The device, as modified, will be marketed under the trade name Minima Pro Stent System.
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