CT LUCIA 621P
FDA premarket approval P100016/S009 · decided 2023-02-07
Approval details
- PMA number
- P100016
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CT LUCIA 621P
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2021-08-23
- Decision date
- 2023-02-07
- Days to decision
- 533 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for a new product model, CT LUCIA 621P, which is a design change to the currently approved product CT LUCIA 611P.
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