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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 TM
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
ORGANOGENESIS, INC.
150 dan rd.
canton, MA 02021
PMA NumberP950032
Supplement NumberS009
Date Received03/25/1999
Decision Date04/19/1999
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 No
Approval Order Statement 
The 30-day notice requested a manufacturing process change for apligraf(tm). The requested change will place into the manufacturing process 3 additional production-scale incubators manufactured by lunaire corporation (model #ci0641w-6spl).
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