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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* ABSORBABLE HEMOSTAT
Classification Nameagent, absorbable hemostatic, non-collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantJOHNSON & JOHNSON MEDICAL, INC.
PMA NumberN12159
Supplement NumberS014
Date Received04/11/1995
Decision Date05/12/1995
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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