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.
Approval for the tecnis foldable acrylic intraocular lens model za9003 with claims regarding reduction in postoperative spherical aberrations compared to lenses with spherical optics and improved night driving simulator performance.
| Device | TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003 |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2005-03-14 |
| Decision Date | 2005-04-13 |
| PMA | P990080 |
| Supplement | S006 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990080 | Original Filing | |
| S056 | 2022-11-09 | 30-day Notice |
| S055 | 2020-12-10 | 30-day Notice |
| S054 | 2020-10-16 | 30-day Notice |
| S053 | ||
| S052 | ||
| S051 | 2019-09-16 | 30-day Notice |
| S050 | 2019-03-04 | 30-day Notice |
| S049 | 2019-02-26 | 30-day Notice |
| S048 | 2018-12-21 | 30-day Notice |
| S047 | 2018-12-21 | 30-day Notice |
| S046 | 2018-04-11 | 30-day Notice |
| S045 | 2017-09-28 | 30-day Notice |
| S044 | 2016-11-02 | 30-day Notice |
| S043 | 2016-06-02 | 30-day Notice |
| S042 | 2016-06-01 | 30-day Notice |
| S041 | 2016-05-18 | 30-day Notice |
| S040 | 2015-12-18 | 30-day Notice |
| S039 | 2015-04-01 | 30-day Notice |
| S038 | 2013-05-24 | 30-day Notice |
| S037 | 2012-04-23 | 30-day Notice |
| S036 | 2011-11-14 | 135 Review Track For 30-day Notice |
| S035 | ||
| S034 | ||
| S033 | 2009-07-30 | 135 Review Track For 30-day Notice |
| S032 | 2008-11-24 | 30-day Notice |
| S031 | 2008-08-29 | 30-day Notice |
| S030 | 2007-12-17 | 135 Review Track For 30-day Notice |
| S029 | 2007-12-14 | 30-day Notice |
| S028 | 2007-10-02 | 30-day Notice |
| S027 | 2007-09-24 | 30-day Notice |
| S026 | 2007-08-09 | 30-day Notice |
| S025 | 2007-06-13 | 30-day Notice |
| S024 | 2007-05-09 | Normal 180 Day Track No User Fee |
| S023 | 2007-04-12 | 30-day Notice |
| S022 | 2007-03-28 | 30-day Notice |
| S021 | 2007-03-27 | 30-day Notice |
| S020 | 2007-02-20 | 30-day Notice |
| S019 | 2007-02-20 | 30-day Notice |
| S018 | 2006-12-19 | 30-day Notice |
| S017 | 2006-12-19 | 30-day Notice |
| S016 | 2006-12-18 | 30-day Notice |
| S015 | 2006-12-18 | 30-day Notice |
| S014 | 2006-12-18 | 30-day Notice |
| S013 | 2006-12-18 | 30-day Notice |
| S012 | 2006-10-12 | 30-day Notice |
| S011 | 2006-10-12 | 30-day Notice |
| S010 | 2006-10-12 | 30-day Notice |
| S009 | 2006-10-10 | 30-day Notice |
| S008 | 2006-05-23 | 135 Review Track For 30-day Notice |
| S007 | ||
| S006 | 2005-03-14 | Real-time Process |
| S005 | 2005-01-03 | Real-time Process |
| S004 | 2003-04-15 | Normal 180 Day Track |
| S003 | 2002-12-23 | Real-time Process |
| S002 | 2002-09-13 | Real-time Process |
| S001 | 2001-09-05 | Real-time Process |