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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 NumberS001
Date Received04/16/2026
Decision Date05/18/2026
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT04415047
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the protocol for the Continued Follow-up of the Premarket Cohort post-approval study (PAS)
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