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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.
 
Trade NameBIOBRANE (R) II BLUE LABEL PRODUCT
Classification Namedressing, wound, drug
Generic Namebiosynthetic wound dressing
ApplicantDOW B. HICKAM, INC.
PMA NumberP870069
Supplement NumberS003
Date Received12/03/1990
Decision Date02/22/1991
Product Code
FRO[ Registered Establishments with FRO ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
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