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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGYNECAR INTERCEED ABSORBABLE ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
ApplicantETHICON, INC.
PMA NumberP880047
Supplement NumberS019
Date Received03/15/2012
Decision Date04/10/2012
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the contract laboratory used for dose audit testing.
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