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.
Addition of an alternate raw material supplier for betacon macromer used in the formulation of lotrafilcon b soft contact lenses.
| Device | LOTRAFILCON B SOFT CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2012-05-04 |
| Decision Date | 2012-05-22 |
| PMA | P010019 |
| Supplement | S032 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010019 | Original Filing | |
| S083 | 2022-06-09 | 30-day Notice |
| S082 | ||
| S081 | 2021-12-17 | 30-day Notice |
| S080 | 2021-08-31 | 30-day Notice |
| S079 | 2021-08-16 | 30-day Notice |
| S078 | 2021-06-04 | Normal 180 Day Track No User Fee |
| S077 | 2020-11-17 | 30-day Notice |
| S076 | 2020-02-18 | 30-day Notice |
| S075 | 2019-12-23 | 30-day Notice |
| S074 | 2019-11-13 | 30-day Notice |
| S073 | 2019-08-02 | 30-day Notice |
| S072 | ||
| S071 | 2019-02-21 | 30-day Notice |
| S070 | 2018-11-27 | 30-day Notice |
| S069 | ||
| S068 | 2018-07-31 | 30-day Notice |
| S067 | 2018-07-13 | 30-day Notice |
| S066 | 2018-06-27 | 30-day Notice |
| S065 | 2018-04-30 | 30-day Notice |
| S064 | 2018-03-22 | 30-day Notice |
| S063 | 2018-02-02 | 30-day Notice |
| S062 | 2017-12-18 | Real-time Process |
| S061 | 2017-10-17 | 30-day Notice |
| S060 | 2017-09-27 | 30-day Notice |
| S059 | 2017-08-29 | 30-day Notice |
| S058 | 2017-08-28 | 30-day Notice |
| S057 | ||
| S056 | 2017-08-09 | 30-day Notice |
| S055 | 2017-06-12 | 30-day Notice |
| S054 | 2017-03-24 | 30-day Notice |
| S053 | 2017-01-23 | 135 Review Track For 30-day Notice |
| S052 | 2016-08-12 | 30-day Notice |
| S051 | 2016-06-01 | 30-day Notice |
| S050 | 2016-04-22 | Normal 180 Day Track |
| S049 | 2016-03-11 | 30-day Notice |
| S048 | 2016-03-01 | 30-day Notice |
| S047 | 2016-02-26 | 30-day Notice |
| S046 | 2016-02-16 | 30-day Notice |
| S045 | 2016-02-09 | 30-day Notice |
| S044 | 2016-01-28 | 30-day Notice |
| S043 | 2015-12-21 | 30-day Notice |
| S042 | 2015-11-12 | 30-day Notice |
| S041 | 2015-09-21 | 30-day Notice |
| S040 | 2015-07-30 | 30-day Notice |
| S039 | 2015-05-01 | 30-day Notice |
| S038 | 2015-04-08 | 30-day Notice |
| S037 | 2015-03-03 | 30-day Notice |
| S036 | 2013-11-12 | 30-day Notice |
| S035 | 2013-08-02 | 30-day Notice |
| S034 | 2012-09-27 | 30-day Notice |
| S033 | 2012-07-10 | 30-day Notice |
| S032 | 2012-05-04 | 30-day Notice |
| S031 | 2012-04-23 | 30-day Notice |
| S030 | 2012-04-16 | 30-day Notice |
| S029 | 2012-02-01 | 30-day Notice |
| S028 | 2011-12-14 | Normal 180 Day Track No User Fee |
| S027 | 2011-12-12 | 30-day Notice |
| S026 | 2011-09-30 | 30-day Notice |
| S025 | 2011-06-06 | Normal 180 Day Track No User Fee |
| S024 | 2011-04-21 | 30-day Notice |
| S023 | 2011-04-13 | 30-day Notice |
| S022 | 2011-03-25 | 135 Review Track For 30-day Notice |
| S021 | 2011-03-01 | Normal 180 Day Track No User Fee |
| S020 | 2011-02-14 | 30-day Notice |
| S019 | 2010-08-09 | 30-day Notice |
| S018 | 2010-08-06 | 30-day Notice |
| S017 | 2010-06-29 | 30-day Notice |
| S016 | ||
| S015 | 2010-05-05 | 30-day Notice |
| S014 | 2010-03-03 | 30-day Notice |
| S013 | 2010-03-02 | 30-day Notice |
| S012 | ||
| S011 | 2008-08-25 | Normal 180 Day Track No User Fee |
| S010 | 2008-07-07 | 30-day Notice |
| S009 | 2008-04-07 | Normal 180 Day Track No User Fee |
| S008 | 2007-12-17 | Real-time Process |
| S007 | 2007-09-14 | Normal 180 Day Track No User Fee |
| S006 | 2007-04-02 | Normal 180 Day Track No User Fee |
| S005 | 2006-11-20 | 30-day Notice |
| S004 | 2006-08-22 | Real-time Process |
| S003 | 2004-06-08 | Normal 180 Day Track |
| S002 | 2003-02-24 | Real-time Process |
| S001 | 2002-04-05 | Normal 180 Day Track |