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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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 HEART VALVES
1851 e. deere ave.
santa ana, CA 92705
HDE NumberH020003
Date Received05/13/2002
Decision Date11/21/2003
Product Code
MWH
Docket Number 03M-0536
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 
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