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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 NumberS001
Date Received08/28/2000
Decision Date09/27/2000
Product Code
DYE[ Registered Establishments with DYE ]
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 for modifications in the design of the device, resulting in model numbers nr-4000-m02, and nr-4000-pa. We have also considered model nr-4000ss, which was not described in the original submission.
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