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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
DeviceAPLIGRAF (GRAFTSKIN)
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
ORGANOGENESIS, INC.
150 dan rd.
canton, MA 02021
PMA NumberP950032
Supplement NumberS011
Date Received04/27/1999
Decision Date06/24/1999
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to use a new keratinocyte cell strain (i. E. , hep 608) in the manufacture of apligraf.
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