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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameMEDTRONIC MELODY TRANSCATHETER PULMONARY VALVE SYSTEM
Classification Namepulmonic valved conduit
Generic Namepulmonic valved conduit
Applicant
Medtronic, Inc.
8200 coral sea st. ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS027
Date Received04/28/2014
Decision Date11/06/2014
Product Code
MWH[ Registered Establishments with MWH ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for various updates to the instructions for use of the device.
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