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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 NumberS005
Date Received02/19/1999
Decision Date03/18/1999
Product Code
MLQ[ Registered Establishments with MLQ ]
Advisory Committee Physical Medicine
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Accepted for an eight-day holding period for filled syringes prior to sterilization.
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