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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 Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
Medtronic, Inc
8200 coral sea street ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS017
Date Received04/02/2013
Decision Date09/24/2013
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Installation of a new reverse osmosis, de-ionized water system.
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