CT LUCIA 202 IOL and CT LUCIA 602 IOL
FDA premarket approval P100016/S004 · decided 2017-08-09
Approval details
- PMA number
- P100016
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CT LUCIA 202 IOL and CT LUCIA 602 IOL
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2017-05-22
- Decision date
- 2017-08-09
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for change in product name from Aaris® EC-3 and Aaris® EC-3 PAL to CT LUCIA 202 and CT LUCIA 602 respectively; minor product labeling changes to include the unit container box, adhesive label, Instructions for Use and patient card; and a new contact/manufacturing address.
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