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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
ApplicantETHICON, Inc.
1000 Rte. 202
Raritan, NJ 08869
PMA NumberP880047
Supplement NumberS054
Date Received01/30/2023
Decision Date02/28/2023
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Adding a duplicate cutter equipment for increasing manufacturing capacity due to the transfer of Neuchatel Surgicel fabric and Interceed device manufacturing to Ethicon, LLC, San Lorenzo in Puerto Rico.
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