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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.
 
Trade NameSURGICEL/SURGICEL NU-KNIT/SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberN12159
Supplement NumberS018
Date Received07/25/2003
Decision Date08/20/2003
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling change to include four antibiotic resistant bacterial strains to the existing list of bacterial strains.
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