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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 Rte. 202
Raritan, NJ 08869
PMA NumberP880047
Supplement NumberS055
Date Received08/22/2023
Decision Date11/14/2023
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for removal of paper Instructions for Use and use of an electronic Instructions for Use for GYNECARE INTERCEED and SURGICEL products.
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