CT LUCIA 621P
FDA premarket approval P100016/S017 · decided 2023-10-02
Approval details
- PMA number
- P100016
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CT LUCIA 621P
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2023-05-12
- Decision date
- 2023-10-02
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for an extension of the shelf life for the subject CT LUCIA 621P intraocular lens (IOL) in BLUESERT injector from 18-months to 36-months.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.