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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 NumberS006
Date Received03/12/1999
Decision Date04/21/1999
Withdrawal Date05/09/2007
Product Code MLQ 
Advisory Committee Physical Medicine
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for extending the expiration dating for ADCON-L Adhesion Control in a Barrier Gel syring configurations from 6 months to 12 months. The device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
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