AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P060022/S010 · decided 2011-10-21
Approval details
- PMA number
- P060022
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2011-02-16
- Decision date
- 2011-10-21
- Days to decision
- 247 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE REMOVAL OF VERBIAGE PERTAINING TO THE CLINICAL ASSESSMENT OF THE ADDITION OF THE ASPHERIC SURFACE.
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