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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
Applicant
Medtronic, Inc.
1851 e. deere ave.
santa ana, CA 92705
HDE NumberH020003
Supplement NumberS007
Date Received08/27/2009
Decision Date09/11/2009
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
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