ACRYSOF MULTIFOCAL POSTERRIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P040020/S019 · decided 2009-07-23
Approval details
- PMA number
- P040020
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACRYSOF MULTIFOCAL POSTERRIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2009-06-30
- Decision date
- 2009-07-23
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- USE OF AN ALTERNATE ETHYLENE OXIDE GAS BLEND STERILANT USED DURING TERMINAL STERILIZATION.
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