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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 E. 42nd St.
Ny, 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
Predetermined Change Control Plan AuthorizedNo
Supplements: S021 S008 S003 S004 S005 S006 S007  S022 S023 S010 S011 
S012 S013 S029 S014 S018 S019 S020 S028 S030 S031 S032 S040 
S038 S016 S017 S027 S025 S024 S036 S033 S034 S035 S039 S037 
S026 S041 
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