Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe
FDA premarket approval P190018/S005 · decided 2021-02-18
Approval details
- PMA number
- P190018
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2020-05-29
- Decision date
- 2021-02-18
- Days to decision
- 265 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for a contract sterilization site located at Synergy Health Sterilisation UK Ltd., Unit 1, Alpha Court, Capitol Park, Thorne, Doncaster DN8 5TZ United Kingdom.
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