CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
FDA premarket approval P030002/S020 · decided 2011-08-05
Approval details
- PMA number
- P030002
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2009-06-02
- Decision date
- 2011-08-05
- Days to decision
- 794 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MARKET CRYSTALENS® MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) WITH A BENZOTRIAZOLE ULTRA-VIOLET (UV) ABSORBER CHROMOPHORE (UVAM). TO BE DESIGNATED AS MODELS AT1UV, AT2UV, HD1UV, HD2UV, AO1UV AND AO2UV.
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