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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.
 
DeviceSURGIFOAM ABSORBABLE GELATIN SPONGE, USP
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantFerrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA NumberP990004
Date Received01/22/1999
Decision Date09/30/1999
Product Code LMF 
Docket Number 99M-4776
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the SURGIFOAM Absorbable Gelatin Sponge, U.S.P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S044 S045 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S066 S067 S068 S069 
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