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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
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantETHICON, Inc.
1000 Rte. 202
Raritan, NJ 08869
PMA NumberN12159
Supplement NumberS050
Date Received10/09/2018
Decision Date11/08/2018
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to strengthen warnings and precautions in the labeling.
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