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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 ABSORABLE ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
ETHICON, INC.
route 22 west
p.o. box 151
somerville, NJ 08876-0151
PMA NumberP880047
Supplement NumberS020
Date Received02/07/2013
Decision Date03/12/2013
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE CONFIGURATION OF THE STERILIZATION PALLET USED FOR STERILIZING THE DEVICE.
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