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.
Consolidation of the cosmetic inspection step of the one-piece and three-piece intraocular lenses
| Device | Tecnis 3-Piece Acrylic Monofocal |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2019-09-16 |
| Decision Date | 2019-10-15 |
| PMA | P990080 |
| Supplement | S051 |
| 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 | 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 |