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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 ANTI-ADHESION CONTROL IN A BARRIER GEL
Generic NameInhibitor, peridural fibrosis (adhesion barrier)
ApplicantWrightmedicaltechnologyinc
5677 Airline Rd.
Arlington, TN 38002
PMA NumberP960057
Supplement NumberS001
Date Received08/28/1998
Decision Date09/11/1998
Withdrawal Date05/09/2007
Product Code MLQ 
Advisory Committee Physical Medicine
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The 30-day Notice requested that FDA review a change in the manufacturing process. A Vertrod Thermal Impulse Heat Sealer will be used in place of an Audion Future Jaw clamp pouch sealer to seal the Tyvek pouch containing the aluminum tube of ADCON(R)-L Adhesion Control Barrier Gel. This change does not affect the currently approved Tyvek seal integrity testing method or specification.
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