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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.
 
DeviceBIOBRANE (R) II BLUE LABEL PRODUCT
Generic NameDressing, wound, drug
ApplicantUDL LABORATORIES, INC.
12720 DAIRY ASHFORD
SUGAR LAND, TX 77478
PMA NumberP870069
Supplement NumberS003
Date Received12/03/1990
Decision Date02/22/1991
Withdrawal Date 01/19/2010
Product Code FRO 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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