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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 NumberS005
Date Received12/03/1997
Decision Date02/09/1998
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 1)the addition of an alternate 60 denier yarn constructed of 24 filaments instead of 18 filaments, and 2) the addition of the alternate final product release site of somerville, New Jersey. The device, as modified, will be marketed under the trade name INTERCEED*(TC7) and is indicated as an adhesion barrier to be used as an adjuvant to gynecologic pelvic surgery.
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