ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC IOL MODELS SN6AD3 AND MN6AD3
FDA premarket approval P040020/S003 · decided 2007-01-30
Approval details
- PMA number
- P040020
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC IOL MODELS SN6AD3 AND MN6AD3
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2006-10-31
- Decision date
- 2007-01-30
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE ADDITION OF A PROLATE SURFACE TO THE ANTERIOR OPTIC, CHANGING THE OPTIC SHAPE FACTOR TO BE MORE EQUICONVEX, AND THE USE OF NATURAL MATERIAL.
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