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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.
 
DeviceTrilogy Transcatheter Heart Valve System
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantJenaValve Technology, Inc.
4 Cromwell
Irvine, CA 92618
PMA NumberP250024
Supplement NumberS003
Date Received06/22/2026
Decision Date07/09/2026
Product Code NPT 
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  
a modification to the receiving inspection sampling plan for delivery system components
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