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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 ADHESION CONTROL IN A BARRIER GEL
Classification Nameinhibitor, peridural fibrosis (adhesion barrier)
Generic Nameinhibitor, peridural fibrosis
ApplicantGLIATECH, INC.
PMA NumberP960057
Supplement NumberS003
Date Received12/21/1998
Decision Date01/14/1999
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 a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the adcon(r)-l adhesion control barrier gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process.
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