ACRYSOF RESTOR INTRAOCULAR LENSES
FDA premarket approval P040020/S007 · decided 2008-02-06
Approval details
- PMA number
- P040020
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACRYSOF RESTOR INTRAOCULAR LENSES
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2007-12-20
- Decision date
- 2008-02-06
- Days to decision
- 48 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- 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.
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