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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 NameENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
Classification Namepulmonic valved conduit
Generic Namepulmonic valved conduit
Applicant
Medtronic, Inc
8200 coral sea street ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS030
Date Received08/21/2014
Decision Date09/20/2014
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 ProductNo
Approval Order Statement 
Approval for various design and manufacturing changes to the luerhub sub-assembly components of the ensemble transcatheter valve delivery system.
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