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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 NameSHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
SHELHIGH, INC.
650 liberty ave.
union, NJ 07083
HDE NumberH980007
Supplement NumberS002
Date Received12/09/2002
Decision Date11/24/2003
Product Code
DYE[ Registered Establishments with DYE ]
Docket Number 99M-4810
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to amend the product labeling to allow patients up to 10 years of age to receive the device and to make the device available in sizes up to a 23mm valve. The device is now indicated for replacement of diseased, damaged or absent pulmonic artery in infants or small children up to age 10 years, with transposition of the great arteries, tnincus arteriosis, tetrology of fallot with associated cardiac anomalies or with pulmonary atresia, or replacement of failed conduits in young patients with accelerated conduit failure.
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