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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.
 
DeviceGYNECARE INTERCEED Absorbable Adhesion Barrier
Generic NameBarrier, absorbable, adhesion
ApplicantETHICON, INC.
1000 Route 202
Raritan, NJ 08869
PMA NumberP880047
Supplement NumberS030
Date Received02/12/2019
Decision Date05/13/2019
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for packaging changes related to the automated process change from manual to automated foiling and cartoning at the Ethicon SARL, Neuchatel Switzerland site for GYNECARE INTERCEED Absorbable Adhesion Barrier.
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