LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS
FDA premarket approval P910061/S013 · decided 2006-07-20
Approval details
- PMA number
- P910061
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 2006-03-30
- Decision date
- 2006-07-20
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR LABELING CHANGES FOR THE ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS AND IS INDICATED TO BE USED FOR PRIMARY IMPLANTATION FOR THE CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION METHODS. THE LENS IS INTENDED FOR PLACEMENT IN THE CILIARY SULCUS OR CAPSULAR BAG.
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