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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameETHICON OMNEX SURGICAL SEALANT
Classification Namesealant,polymerizing
Generic Namevascular sealant
ApplicantETHICON, INC.
PMA NumberP060029
Supplement NumberS004
Date Received05/30/2012
Decision Date06/29/2012
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer of the incoming inspection process from ethicon, inc. In raleigh, north carolina to ethicon llc in san lorenzo, puerto rico.
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