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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 Transcatheter Pulmonary System
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantMedtronic, Inc.
3576 Unocal Place
Building A
Santa Rosa, CA 95403
PMA NumberP200046
Supplement NumberS002
Date Received04/23/2021
Decision Date05/21/2021
Product Code NPV 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.
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