ACRYSOF ASPHERIC UV ABSORBING INTRAOCULAR LENSES (IOLS)
FDA premarket approval P930014/S076 · decided 2015-03-10
Approval details
- PMA number
- P930014
- Supplement
- S076
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF ASPHERIC UV ABSORBING INTRAOCULAR LENSES (IOLS)
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2014-12-16
- Decision date
- 2015-03-10
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE ACRYSOF® ASPHERIC UV ABSORBING INTRAOCULAR LENS (IOL) MODEL SA60WF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF® ASPHERIC UV ABSORBING INTRAOCULAR LENSES (IOLS) AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. THIS LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
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510(k) clearances by this applicant
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