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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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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