AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System
FDA premarket approval P930014/S124 · decided 2020-01-09
Approval details
- PMA number
- P930014
- Supplement
- S124
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2019-07-15
- Decision date
- 2020-01-09
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for a manufacturing site located at Alcon Laboratories Ireland, Ltd.; Cork Business and Technology Park Model Farm Road Cork Ireland.
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