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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*(TC7) ABSORBABLE ADHESION BARRIER
Generic NameBarrier, absorbable, adhesion
ApplicantETHICON, INC.
1000 Route 202
Raritan, NJ 08869
PMA NumberP880047
Supplement NumberS007
Date Received12/22/1998
Decision Date05/24/1999
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for revised labeling to reflect a recent study finding that laproscopic use increased adhesions compared to the control group.
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