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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 NumberS043
Date Received08/06/2025
Decision Date09/05/2025
Product Code NPV 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a revision to the Instructions for Use to add a warning statement related to inspection of the valve container for damage.
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