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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
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
Medtronic, Inc
8200 coral sea street ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS023
Date Received11/08/2013
Decision Date02/11/2014
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a new melody® transcatheter pulmonary valve (tpv) model.
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