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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 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.
 
DeviceTRANSCYTE
Generic NameDressing, wound and burn, interactive
ApplicantShire Regenerative Medicine
11095 Torreyana Rd.
San Diego, CA 92121
PMA NumberP960007
Supplement NumberS011
Date Received08/19/1999
Decision Date11/26/1999
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changing the frequency of the in-process sterility testing conducted on the device.
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