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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 NumberS006
Date Received03/12/1999
Decision Date04/21/1999
Product Code
MLQ[ Registered Establishments with MLQ ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extending the expiration dating for adcon-l adhesion control in a barrier gel syring configurations from 6 months to 12 months. The device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
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