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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 Namepulmonary valve prosthesis percutaneously delivered
Generic Namepulmonary valve prosthesis percutaneously delivered
Applicant
Medtronic, Inc.
8200 coral sea st. ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS018
Date Received04/15/2013
Decision Date07/31/2013
Product Code
NPV[ Registered Establishments with NPV ]
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 to use two new autoclaves.
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