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.
Notification of an additional rotlex iola plus lens analyzer used during the manufacturing process.
| Device | SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS |
| Generic Name | Intraocular Lens |
| Applicant | LENSTEC, INC. |
| Date Received | 2014-12-15 |
| Decision Date | 2015-01-15 |
| PMA | P090022 |
| Supplement | S024 |
| 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 | LENSTEC, INC. 1765 Commerce Ave N st. Petersburg, FL 33716 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090022 | Original Filing | |
| S039 | 2021-09-02 | 30-day Notice |
| S038 | 2020-12-11 | 30-day Notice |
| S037 | 2020-09-23 | 30-day Notice |
| S036 | 2020-09-21 | 30-day Notice |
| S035 | 2018-08-07 | 30-day Notice |
| S034 | 2017-05-12 | 30-day Notice |
| S033 | ||
| S032 | 2017-02-17 | 30-day Notice |
| S031 | 2017-01-12 | 30-day Notice |
| S030 | 2016-12-19 | 30-day Notice |
| S029 | 2016-08-29 | 30-day Notice |
| S028 | 2016-08-29 | 30-day Notice |
| S027 | 2016-01-20 | 30-day Notice |
| S026 | 2015-12-23 | Real-time Process |
| S025 | 2015-09-30 | 135 Review Track For 30-day Notice |
| S024 | 2014-12-15 | 30-day Notice |
| S023 | 2014-06-16 | 30-day Notice |
| S022 | 2014-05-12 | Real-time Process |
| S021 | 2014-03-19 | 30-day Notice |
| S020 | 2014-03-18 | Normal 180 Day Track |
| S019 | 2013-08-27 | 30-day Notice |
| S018 | 2013-06-07 | 30-day Notice |
| S017 | 2013-05-22 | Real-time Process |
| S016 | 2013-03-08 | 30-day Notice |
| S015 | 2013-01-29 | 30-day Notice |
| S014 | 2012-08-27 | 30-day Notice |
| S013 | 2012-07-24 | Special (immediate Track) |
| S012 | 2012-04-20 | Normal 180 Day Track |
| S011 | 2012-03-14 | Real-time Process |
| S010 | 2011-11-02 | Normal 180 Day Track No User Fee |
| S009 | 2011-08-31 | 135 Review Track For 30-day Notice |
| S008 | 2011-08-29 | 30-day Notice |
| S007 | 2011-08-18 | 135 Review Track For 30-day Notice |
| S006 | 2011-07-28 | 30-day Notice |
| S005 | 2011-07-26 | Real-time Process |
| S004 | 2010-12-15 | Real-time Process |
| S003 | ||
| S002 | 2010-07-02 | Real-time Process |
| S001 | 2010-05-13 | Real-time Process |