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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 FAMILY OF 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 NumberS032
Date Received08/15/2013
Decision Date09/12/2013
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
IMPLEMENT A NEW AUTOMATIC CARTONER FOR THE SURGICEL ABSORBABLE HEMOSTAT PACKAGED MATERIAL.
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