Clareon Aspheric UV Absorbing IOL, Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Devi
FDA premarket approval P190018/S003 · decided 2020-07-20
Approval details
- PMA number
- P190018
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Clareon Aspheric UV Absorbing IOL, Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Devi
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2020-04-30
- Decision date
- 2020-07-20
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for Clareon Aspheric UV Absorbing intraocular lens (IOL) Model CC60WF and Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Device Model CCA0T0.
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