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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.
 
DeviceSURGIFOAM ABSORBABLE GELATIN SPONGE, USP
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
FERROSAN MEDICAL DEVICES A/S
p.o. box 151 route 22 west
somerville, NJ 08876
PMA NumberP990004
Date Received01/22/1999
Decision Date09/30/1999
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 99M-4776
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 
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