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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.
 
DeviceGELFOAM
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPFIZER, INC.
235 EAST 42ND ST.
NEW YORK, NY 10017
PMA NumberN18286
Supplement NumberS004
Date Received11/27/1989
Decision Date05/23/1990
Product Code LMF 
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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