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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 NumberS035
Date Received08/18/2003
Decision Date09/15/2003
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 
Substitution of the current manufacturer (eli lilly and co. , distributed by gibco) to a different manufacturer (novo nordisk s/a, distributed by gibco). Also, substituting non-human components with human components.
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