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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 NameINTERCEED*(TC7) ABSORBABLE ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
ApplicantETHICON, INC.
PMA NumberP880047
Supplement NumberS007
Date Received12/22/1998
Decision Date05/24/1999
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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