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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(R)-L ADHESION CONTROL IN A BARRIER GEL
Generic NameInhibitor, peridural fibrosis (adhesion barrier)
ApplicantWrightmedicaltechnologyinc
5677 Airline Rd.
Arlington, TN 38002
PMA NumberP960057
Supplement NumberS011
Date Received06/26/2000
Decision Date09/27/2000
Withdrawal Date05/09/2007
Product Code MLQ 
Advisory Committee Physical Medicine
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO PROCEDURES USED FOR THE MANUFACTURE AND TESTING OF THE DEVICE. 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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