Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric
FDA premarket approval P190018/S006 · decided 2020-09-29
Approval details
- PMA number
- P190018
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2020-08-31
- Decision date
- 2020-09-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Addition of an alternate supplier for the AutonoMe Delivery System nozzle component (V.3.6).
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