|
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 | S003 |
Date Received | 12/21/1998 |
Decision Date | 01/14/1999 |
Withdrawal Date
|
05/09/2007 |
Product Code |
MLQ |
Advisory Committee |
Physical Medicine |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-Day Notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the Adcon(R)-L Adhesion Control Barrier Gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process. |