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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.
 
DeviceINTERCEED ABSORBABLE ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
ETHICON, INC.
route 22 west
p.o. box 151
somerville, NJ 08876-0151
PMA NumberP880047
Supplement NumberS013
Date Received05/06/2009
Decision Date06/24/2009
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
MODIFICATION OF A PROCESSING AID IN THE MANUFACTURING OF THE DEVICE.
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