CT LUCIA 602, CT LUCIA 202
FDA premarket approval P100016/S019 · decided 2023-10-10
Approval details
- PMA number
- P100016
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CT LUCIA 602, CT LUCIA 202
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2023-09-15
- Decision date
- 2023-10-10
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- a modification of the heparin fixture
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.