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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.
 
DeviceETHICON OMNEX SURGICAL SEALANT APPLICATOR AND PACKAGING
Generic NameSealant, polymerizing
ApplicantETHICON, Inc.
Rte. 22 W.
Somerville, NJ 08876
PMA NumberP060029
Supplement NumberS001
Date Received07/09/2010
Decision Date09/07/2010
Withdrawal Date10/18/2021
Product Code NBE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE APPLICATOR AND PACKAGING.
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