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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 Namepulmonic valved conduit
Generic Namepulmonic valved conduit
Applicant
Medtronic, Inc.
8200 coral sea st. ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS020
Date Received05/08/2013
Decision Date07/12/2013
Product Code
MWH[ Registered Establishments with MWH ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for a design change to the primary packaging of the melody transcatheter pulmonary valve (model pbi 0) and the contegra pulmonary valvedconduit (model 200 and 200s).
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