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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 CONDUIT
Classification Namepulmonic valved conduit
Generic Namepulmonic valved conduit
Applicant
Medtronic, Inc.
1851 e. deere ave.
santa ana, CA 92705
HDE NumberH020003
Supplement NumberS031
Date Received04/08/2016
Decision Date05/04/2016
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 
Add bovine tissue suppliers used to manufacture the conduit.
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