CT LUCIA 621P
FDA premarket approval P100016/S016 · decided 2023-05-09
Approval details
- PMA number
- P100016
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CT LUCIA 621P
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2023-02-10
- Decision date
- 2023-05-09
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for a modification of the injector component of the CT LUCIA 621P.
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