ULTRAVIOLET (UV) ABSORBING AND NON-UV ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL)
FDA premarket approval P840039/S055 · decided 2006-04-24
Approval details
- PMA number
- P840039
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ULTRAVIOLET (UV) ABSORBING AND NON-UV ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL)
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2005-11-22
- Decision date
- 2006-04-24
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A CHANGE IN THE LENS CARRIER TO A ROTARY CAP CARRIER.
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| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
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