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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 NumberS023
Date Received08/26/2016
Decision Date09/20/2016
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of second sensor on the band sealing equipment that seals the open side of the foil pouch of the SURGICEL Family of Absorbable Hemostats and GYNECARE INTERCEED Absorbable Adhesion Barrier products manufactured at Ethicon, Sarl.
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