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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
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
ORGANOGENESIS, INC.
150 dan rd.
canton, MA 02021
PMA NumberP950032
Supplement NumberS041
Date Received05/26/2005
Decision Date06/20/2005
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes to formulations used in the apligraf manufacturing process.
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