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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 ABSORBABLE HEMOSTAT (SURGICEL, SURGICEL NU-KNIT AND SURGICEL FIBRILLAR ABSORBABLE HEMOSTATS)
Classification Nameagent, absorbable hemostatic, non-collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
PMA NumberN12159
Supplement NumberS023
Date Received04/04/2008
Decision Date11/26/2008
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing sites located at: 1) ethicon sarl, neuchatel, switzerland; 2) ethicon sarl, marin switzerland (warehouse); and 3) studer af/werk hard, daniken, switzerland (contract sterilizer).
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