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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.
 
DeviceMelody™ Transcatheter Pulmonary Valve System
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantMedtronic, Inc.
8200 Coral Sea St. NE Mvs83
Mounds View, MN 55112
PMA NumberP140017
Supplement NumberS021
Date Received02/28/2022
Decision Date03/01/2022
Product Code NPV 
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  
Use of a new data management system for microbiology laboratory test data and data reporting at the Medtronic Tijuana facility for the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX Transcatheter Aortic Valves (TAVs), Harmony and Melody Transcatheter Pulmonic Valves (TPV), and Avalus bioprosthesis products.
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