ACRYSOF RESTOR INTRAOCULAR LENSES
FDA premarket approval P040020/S036 · decided 2011-10-31
Approval details
- PMA number
- P040020
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF RESTOR INTRAOCULAR LENSES
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2011-09-01
- Decision date
- 2011-10-31
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR MODIFICATIONS TO THE ACRYSOF® INTRAOCULAR LENS (IOL) CASE (#79 AND #80) DRAINAGE FEATURES.
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