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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.
Arlington, TN 38002
PMA NumberP960057
Supplement NumberS002
Date Received11/03/1998
Decision Date11/25/1998
Withdrawal Date05/09/2007
Product Code MLQ 
Docket Number N
Advisory Committee Physical Medicine
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in ADCON-L kit packaging configuration, i.e., replacing the aluminum tube with a polypropylene syringe, and replacing the PVC application with a polypropylene applicator.
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