LI61AO LENS
FDA premarket approval P910061/S015 · decided 2006-12-06
Approval details
- PMA number
- P910061
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LI61AO LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 2006-08-30
- Decision date
- 2006-12-06
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO ADD A STATEMENT TO THE DIRECTIONS FOR USE THAT THE SOFPORT MODEL LI61 AO IOL HAS PROLATE ASPHERIC SURFACES AND IS DESIGNED TO BE FREE OF SPHERICAL ABERRATIONS, AND TO ADD A FIGURE WITH THE MODULATION TRANSFER FUNCTIONS FOR THE LI61AO AND LI61SE LENSES.
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