ACRYSOF RESTOR NATURAL IOL MODELS SN60D3 AND MN60D3
FDA premarket approval P040020/S001 · decided 2005-07-29
Approval details
- PMA number
- P040020
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF RESTOR NATURAL IOL MODELS SN60D3 AND MN60D3
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2005-07-12
- Decision date
- 2005-07-29
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR ACRYSOF RESTOR NATURAL INTRAOCULAR LENS (IOL) MODELS SN60D3 AND MN60D3 (LEVEL A MODIFICATION: ADDITION OF CHROMOPHORE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF RESTOR NATURAL IOL AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO THE REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THE LENS IS INTE
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