ACRYSOF RESTOR MULTIFOCAL POSTERIOR INTRAOCULAR LENSES
FDA premarket approval P040020/S052 · decided 2014-01-13
Approval details
- PMA number
- P040020
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACRYSOF RESTOR MULTIFOCAL POSTERIOR INTRAOCULAR LENSES
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2013-12-19
- Decision date
- 2014-01-13
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- REDUCE FREQUENCY OF A MANUFACTURING INSPECTION FROM A 100% INSPECTION RATE TO A SAMPLE-BASED INSPECTION PLAN FOR DEVICES WITHIN A LOT.
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