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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGELFOAM
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPFIZER, INC.
235 EAST 42ND ST.
NEW YORK, NY 10017
PMA NumberN18286
Date Received02/22/1979
Decision Date07/08/1983
Product Code LMF 
Docket Number 83M-0243
Notice Date 08/29/1983
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Supplements:  S003 S004 S005 S006 S007 S008 S010 S011 S012 S013 S014 
S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 
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