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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*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
1000 Route 202
Raritan, NJ 08869
PMA NumberN12159
Supplement NumberS013
Date Received09/15/1993
Decision Date01/16/1996
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL 1)PROCESS CHANGE THAT DELETES THE USE OF THE IN-PROCESS SOLVENT FREON AND REPLACES IT WITH PERFLUOROHEXANE 2) CHANGE OF IN-PROCESS MANUFACTURING FACILITY TO NORAMCO, INC., 1440 OLYMPIC DR., P.O. BOX 800001, ATHENS, GA 30608-8001 3)CHANGE OF QUALITY ASSURANCE SITE TO, JOHNSON AND JOHNSON MEDICAL, INC., U.S. HIGHWAY 75S AND 1417W, SHERMAN, TX 75091-9100 4)ADDITION OF ALTERNATE STERILIZATION SITE, JOHNSON & JOHNSON MEDICAL, INC., U.S. HIGHWAY 75S AND 1417W, SHERMAN, TX 75091-9100
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