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 modifications to the optic body shape and overalldiameter of your softec hd lens to introduce a lens with an ovoid optic and overall diameter of 12. 50 mm and changes to your labeling related to the introduction of the modified lens. The device, as modified, will be marketed under the trade name softec hdo and is indicated for the replacement of the human crystalline lens following phacoemulsifica- tion cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.
| Device | SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) |
| Generic Name | Intraocular Lens |
| Applicant | LENSTEC, INC. |
| Date Received | 2012-03-14 |
| Decision Date | 2012-06-11 |
| PMA | P090022 |
| Supplement | S011 |
| 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 | 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 |