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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 NameSHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT
Classification Namepulmonic replacement heart valve
Generic Namepulmonic replacement heart valve
Regulation Number870.3925
Applicant
SHELHIGH, INC.
650 liberty ave.
union, NJ 07083
HDE NumberH980007
Date Received10/20/1998
Decision Date09/30/1999
Product Code
PAL
Docket Number 99M-4810
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
For replacement of the diseased, damaged, or absent pulmonic artery in small children or infants up to age 4 years, with transposition of the great arteries, truncus arteriosis, tetrology of fallot with associated cardiac anomalies or with pulmonary atresia, or replacement of failed conduits in young patients with accelereated conduit failure.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 
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