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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 FIBRILLAR ABSORBABLE HEMOSTATT
Classification Nameagent, absorbable hemostatic, non-collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberN12159
Supplement NumberS016
Date Received03/04/1996
Decision Date05/15/1996
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 4"x4" size of surgicel fibrillar absorbable hemostat.
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