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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameinhibitor, peridural fibrosis (adhesion barrier)
Generic Nameinhibitor, peridural fibrosis (adhesion barrier)
5677 airline rd.
arlinton, TN 38002
PMA NumberP960057
Supplement NumberS001
Date Received08/28/1998
Decision Date09/11/1998
Product Code
MLQ[ Registered Establishments with MLQ ]
Advisory Committee Physical Medicine
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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.