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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAPLIGRAF TM
Generic NameDressing, wound and burn, interactive
ApplicantOrganogenesis, Inc.
150 Dan Rd.
Canton, MA 02021
PMA NumberP950032
Supplement NumberS009
Date Received03/25/1999
Decision Date04/19/1999
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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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