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Device | ACRYSOF RESTOR INTRAOCULAR LENSES |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S007 |
Date Received | 12/20/2007 |
Decision Date | 02/06/2008 |
Product Code |
MFK |
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 ADDITION OF INFORMATION: 1) CLARIFYING THE OPTIKOS MODULATION TRANSFER FUNCTION (MTF) TEST PROCEDURE THAT WAS REVISED; 2) PROVIDING THE SUPPLEMENTARY DATA AND VALIDATION DATA FOR THE SOFTWARE OF THE OPTIKOS MTF BENCH; AND 3) PROVIDING THE SOFTWARE VALIDATION FOR THE ADDITIONAL OPTIKOS MTF SYSTEM TO TEST MULTIFOCAL LENSES. |