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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
Applicant
Medtronic, Inc
8200 coral sea street ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS009
Date Received07/11/2012
Decision Date08/27/2012
Notice Date 08/23/2012
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 of the reporting due date to be moved from january 24 to july 26 to aid fda our preparations for the annual pediatric advisory committee (pac) meeting.
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