CT Lucia 602, CT Lucia 202, CT Lucia 611P
FDA premarket approval P100016/S012 · decided 2022-03-25
Approval details
- PMA number
- P100016
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CT Lucia 602, CT Lucia 202, CT Lucia 611P
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2022-03-03
- Decision date
- 2022-03-25
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Addition of validated ethylene oxide sterilization Chamber #9 with its validated Cycle #834 to the routine sterilization process.
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