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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
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
Applicant
ETHICON, INC.
route 22 west
somerville, NJ 08876
PMA NumberP060029
Supplement NumberS004
Date Received05/29/2012
Decision Date06/29/2012
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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