This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | CT Lucia 602, CT Lucia 202, CT Lucia 611P |
| Generic Name | Intraocular Lens |
| Applicant | Carl Zeiss Meditec Production LLC1040 South Vintage Avenue, Bldg. Aontario, CA 91761-3631 PMA NumberP100016 Supplement NumberS014 Date Received04/26/2022 Decision Date05/13/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-26 |
| Decision Date | 2022-05-13 |
| PMA | P100016 |
| Supplement | S014 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Carl Zeiss Meditec Production LLC 1040 South Vintage Avenue, Bldg. A ontario, CA 91761-3631 PMA NumberP100016 Supplement NumberS014 Date Received04/26/2022 Decision Date05/13/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement changing The Measurement System Used For Hydrophobic Button Diameter Measurements In CT Lucia 602, CT Lucia 202, And CT Lucia 611P Intraocular Lens Production |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100016 | Original Filing | |
| S015 | 2022-12-09 | 30-day Notice |
| S014 | 2022-04-26 | 30-day Notice |
| S013 | 2022-03-25 | 30-day Notice |
| S012 | 2022-03-03 | 30-day Notice |
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | 2020-09-08 | Normal 180 Day Track |
| S007 | 2020-08-31 | 135 Review Track For 30-day Notice |
| S006 | 2018-08-24 | 30-day Notice |
| S005 | 2018-02-08 | 30-day Notice |
| S004 | 2017-05-22 | Normal 180 Day Track No User Fee |
| S003 | 2017-03-24 | Special (immediate Track) |
| S002 | 2014-12-18 | Normal 180 Day Track No User Fee |
| S001 | 2013-02-19 | Normal 180 Day Track No User Fee |