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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 ABSORBABLE HEMOSTAT (SURGICEL, SURGICEL NU-KNIT AND SURGICEL FIBRILLAR ABSORBABLE HEMOSTATS)
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 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/sterilizer/packager/supplier
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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