RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P040020/S018 · decided 2009-10-29
Approval details
- PMA number
- P040020
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2009-06-18
- Decision date
- 2009-10-29
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A CHANGE IN THE LENS HOLDER IN THE MANUFACTURING PROCESS OF THE DEVICE.
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