MODEL LI51U & LI61U SOFLEX UV-ABSORBING SILICONE PC IOL
FDA premarket approval P910061/S001 · decided 1997-10-21
Approval details
- PMA number
- P910061
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL LI51U & LI61U SOFLEX UV-ABSORBING SILICONE PC IOL
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 1997-06-10
- Decision date
- 1997-10-21
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the Models LI51U and LI61U IOLs.
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