ACRYSOF IQ RESTOR +3.0D ADD POWER POSTERIOR CHAMBER IOLS
FDA premarket approval P040020/S029 · decided 2011-06-30
Approval details
- PMA number
- P040020
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACRYSOF IQ RESTOR +3.0D ADD POWER POSTERIOR CHAMBER IOLS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2010-11-01
- Decision date
- 2011-06-30
- Days to decision
- 241 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON LABORATORIES IRELAND LTD. IN CORK, IRELAND.
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