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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.
 
Trade NameADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
Classification Nameinhibitor, peridural fibrosis (adhesion barrier)
Generic Nameinhibitor, peridural fibrosis
ApplicantGLIATECH, INC.
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: manufacturing
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.
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