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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSURGIFOAM ABSORBABLE GELATINE 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
Supplement NumberS024
Date Received04/22/2014
Decision Date07/02/2014
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing (packaging) site located at ferrosan medical devices, koksowa, poland.
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