ACRYSOF NATURAL SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL SB30AL)
FDA premarket approval P930014/S009 · decided 2003-06-24
Approval details
- PMA number
- P930014
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF NATURAL SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL SB30AL)
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2001-12-26
- Decision date
- 2003-06-24
- Days to decision
- 545 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS (MODEL SB30AL). THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICA-TION ARE PERFORMED. THESE LENSES ARE INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
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