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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 street ne
mounds view, MN 55112
PMA NumberP140017
Supplement NumberS007
Date Received04/19/2017
Decision Date05/19/2017
Product Code NPV 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Changes to endotoxin and bioburden testing for the Ensemble and Ensemble II Delivery Systems.