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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceETHICON OMNEX SURGICAL SEALANT
Generic NameSealant, polymerizing
ApplicantETHICON, INC.
ROUTE 22 WEST
SOMERVILLE, NJ 08876
PMA NumberP060029
Date Received10/26/2006
Decision Date06/03/2010
Withdrawal Date 10/18/2021
Product Code NBE 
Docket Number 10M-0285
Notice Date 06/11/2010
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ETHICON OMNEX SURGICAL SEALANT. THE DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S003 S005 S004 S001 
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