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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.
 
DeviceINTERCEED ABSORBABLE 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 NumberS012
Date Received04/22/2008
Decision Date11/26/2008
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MANUFACTURING SITES LOCATED AT: 1) ETHICON SARL, NEUCHATEL, SWITZERLAND; 2) ETHICON SARL, MARIN SWITZERLAND (WAREHOUSE); AND 3) STUDER AF/WERK HARD, DANIKEN, SWITZERLAND (CONTRACT STERILIZER).
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