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. |
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Device | ADCON -L ADHESION CONTROL IN A BARRIER GEL |
Generic Name | Inhibitor, peridural fibrosis (adhesion barrier) |
Applicant | WRIGHTMEDICALTECHNOLOGYINC 5677 AIRLINE RD. ARLINTON, TN 38002 |
PMA Number | P960057 |
Supplement Number | S002 |
Date Received | 11/03/1998 |
Decision Date | 11/25/1998 |
Withdrawal Date
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05/09/2007 |
Product Code |
MLQ |
Docket Number | N |
Advisory Committee |
Physical Medicine |
Supplement Type | Real-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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