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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 NumberS002
Date Received11/03/1998
Decision Date11/25/1998
Product Code
MLQ[ Registered Establishments with MLQ ]
Docket Number N
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in adcon-l kit packaging configuration, i. E. , replacing the aluminum tube with a polypropylene syringe, and replacing the pvc application with a polypropylene applicator.
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