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 a new foldable, ultraviolet light-absorbing, posterior chamber intraocular lens model. The device, as modified, will be marketed under the trade name model z9000 and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification. The lens is intended to be placed in the capsular bag.
| Device | SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2001-09-05 |
| Decision Date | 2001-10-16 |
| PMA | P990080 |
| Supplement | S001 |
| 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 |