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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.
 
DeviceHarmony™ TPV System
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantMedtronic, Inc.
3576 Unocal Pl.
Bldg. A
Santa Rosa, CA 95403
PMA NumberP200046
Supplement NumberS048
Date Received02/04/2026
Decision Date03/06/2026
Product Code NPV 
Advisory Committee Cardiovascular
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 of the revised protocols for PAS1, "Continued Follow-up of the Harmony TPV IDE Cohort," and PAS2, "Harmony TPV New Enrollment Study." The PAS protocols have been submitted to comply with the conditions of approval outlined in the approval order for P200046.
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