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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.
 
DeviceSURGICEL FIBRILLAR ABSORBABLE HEMOSTATT
Classification Nameagent, absorbable hemostatic, non-collagen based
Generic Nameagent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
Applicant
ETHICON, INC.
route 22 west
somerville, NJ 08876
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/material
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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