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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, Inc.
1851 e. deere ave.
santa ana, CA 92705
HDE NumberH020003
Date Received05/13/2002
Decision Date11/21/2003
Product Code
MWH[ Registered Establishments with MWH ]
Docket Number 03M-0536
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the contegram pulmonary valved conduit, models 200 (unsupported) and 200s (supported). This device is indicated for use in patients under 18 years of age for the correction or reconstruction of the right ventricular outflow tract (rvot) in the following congenital heart malformations: pulmonary stenosis, tetralogy of fallot, truncus arteriosus, transposition with ventricular septal defect (vsd), pulmonary atresia; in addition, the contegrab pulmonary valved conduit is indicated for the replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits. The device is to be available in the following sizes: 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, and 22 mm (measurement made at the inside diameter of the conduit's inflow side); minimum overall length of 10 cm, except for the 12-mm size, which is about 7 cm long.
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 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 
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