This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the softec hd posterior chamber intraocular lens (pciol). The device is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.
Device | LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS |
Classification Name | Intraocular Lens |
Generic Name | Intraocular Lens |
Applicant | LENSTEC, INC. |
Date Received | 2009-09-01 |
Decision Date | 2010-04-12 |
Notice Date | 2010-04-23 |
PMA | P090022 |
Supplement | S |
Product Code | HQL |
Docket Number | 10M-0220 |
Advisory Committee | Ophthalmic |
Expedited Review | No |
Combination Product | No |
Applicant Address | LENSTEC, INC. 1765 Commerce Ave N st. Petersburg, FL 33716 |
Summary: | Summary of Safety and Effectiveness |
Labeling: | Labeling |
Approval Order: | Approval Order |
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 |