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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.
 
DeviceADCON-L ADHESION CONTROL IN A BARRIER GEL
Generic NameInhibitor, peridural fibrosis (adhesion barrier)
ApplicantWRIGHTMEDICALTECHNOLOGYINC
5677 AIRLINE RD.
ARLINTON, TN 38002
PMA NumberP960057
Supplement NumberS005
Date Received02/19/1999
Decision Date03/18/1999
Withdrawal Date 05/09/2007
Product Code MLQ 
Advisory Committee Physical Medicine
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Accepted for an eight-day holding period for filled syringes prior to sterilization.
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