|
Device | AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place Santa Ana, CA 92705 |
PMA Number | P880031 |
Supplement Number | S013 |
Date Received | 10/15/1999 |
Decision Date | 11/08/1999 |
Withdrawal Date
|
03/03/2011 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to 1) extend the finished product UV absorbance specification from 0.012 AU to 0.016 AU and 2) eliminate the UV absorbance specification from the 24 month shelf-life. |