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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameGELFOAM
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent
Regulation Number878.4490
ApplicantPFIZER, INC.
PMA NumberN18286
Date Received02/22/1979
Decision Date07/08/1983
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 83M-0243
Notice Date 08/29/1983
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements: S003 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S016 S017 S018 S019 S020 S021 S022 
S023 S024 S025 S026 
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