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.
Implementation of a strip blister inspection system at the packaging lines in the production of lotrafilcon a and lotrafilcon b soft contact lenses at alcon's batam, indonesia production facility.
| Device | Lotrafilcon A and 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 | 2018-06-27 |
| Decision Date | 2018-07-24 |
| PMA | P010019 |
| Supplement | S066 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |