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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 NameMELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
Classification Namepulmonary valve prosthesis percutaneously delivered
Generic Namepulmonary valve prosthesis percutaneously delivered
Applicant
Medtronic, Inc
8200 coral sea street ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS002
Date Received03/19/2010
Decision Date09/02/2010
Product Code
NPV[ Registered Establishments with NPV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the post-approval study protocol.
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