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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceADCON -L ADHESION CONTROL IN A BARRIER GEL
Classification Nameinhibitor, peridural fibrosis (adhesion barrier)
Generic Nameinhibitor, peridural fibrosis (adhesion barrier)
Applicant
WRIGHTMEDICALTECHNOLOGYINC
5677 airline rd.
arlinton, TN 38002
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 - manufacturer/sterilizer/packager/supplier
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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