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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 NameContegra Pulmonary Valved Conduct
Classification Namepulmonic valved conduit
Generic Namepulmonic valved conduit
Medtronic, Inc.
1851 e. deere ave.
santa ana, CA 92705
HDE NumberH020003
Supplement NumberS033
Date Received09/11/2017
Decision Date10/03/2017
Product Code
MWH[ Registered Establishments with MWH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
A reduction of the sample size for tissue microbial monitoring.