SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL LI63U
FDA premarket approval P910056/S007 · decided 1999-12-16
Approval details
- PMA number
- P910056
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL LI63U
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 1999-11-24
- Decision date
- 1999-12-16
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approvalfor Model LI63U and to use MED-6812SH silicone material as an alternative to RMX-3 silicone for models with polyimide haptics approved under this PMA.
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