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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOMNEX SURGICAL SEALANT
Classification Namesealant,polymerizing
Generic Namevascular sealant
ApplicantETHICON, INC.
PMA NumberP060029
Date Received10/26/2006
Decision Date06/03/2010
Product Code
NBE[ Registered Establishments with NBE ]
Docket Number 10M-0285
Notice Date 06/11/2010
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S003 S004 S005 
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