|
Device | CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 SANTA ANA, CA 92705-4933 |
PMA Number | P810055 |
Supplement Number | S072 |
Date Received | 05/29/2008 |
Decision Date | 07/02/2008 |
Withdrawal Date
|
04/15/2009 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF THE MEASURING IOL QUALITY SYSTEM FOR DETERMINING OPTICAL PERFORMANCE OF IOLS MANUFACTURED AT THE FACILITY. |