CT Lucia 602
FDA premarket approval P100016/S011 · decided 2022-07-14
Approval details
- PMA number
- P100016
- Supplement
- S011
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CT Lucia 602
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2022-03-03
- Decision date
- 2022-07-14
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for qualifying a new package tester.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.