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.
Device | AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses |
Generic Name | Lens, Multifocal Intraocular |
Applicant | Alcon Research, Ltd.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS104 Date Received11/22/2022 Decision Date12/20/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-11-22 |
Decision Date | 2022-12-20 |
PMA | P040020 |
Supplement | S104 |
Product Code | MFK |
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 Research, Ltd. 6201 South Freeway fort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS104 Date Received11/22/2022 Decision Date12/20/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement change From Two Fixtures To A Single Fixture Used For Lens Cleaning, Extraction, Vacuum Drying And Plasma Treatment Processes |
Supplement Number | Date | Supplement Type |
---|---|---|
P040020 | Original Filing | |
S104 | 2022-11-22 | 30-day Notice |
S103 | 2022-04-22 | 30-day Notice |
S102 | 2022-03-01 | 30-day Notice |
S101 | 2021-09-21 | 30-day Notice |
S100 | ||
S099 | 2021-06-16 | 30-day Notice |
S098 | 2021-03-26 | 30-day Notice |
S097 | 2020-11-25 | 30-day Notice |
S096 | 2020-09-10 | 30-day Notice |
S095 | 2020-07-31 | Normal 180 Day Track No User Fee |
S094 | ||
S093 | ||
S092 | 2019-09-11 | 30-day Notice |
S091 | 2019-07-05 | 30-day Notice |
S090 | 2019-03-25 | 30-day Notice |
S089 | 2019-03-25 | 30-day Notice |
S088 | 2019-03-01 | Real-time Process |
S087 | 2019-01-31 | Panel Track |
S086 | 2018-11-20 | 30-day Notice |
S085 | 2018-11-07 | 30-day Notice |
S084 | 2018-10-05 | 30-day Notice |
S083 | 2018-09-12 | 30-day Notice |
S082 | 2018-09-10 | 30-day Notice |
S081 | 2018-09-07 | 30-day Notice |
S080 | 2018-07-19 | 30-day Notice |
S079 | 2018-05-02 | Real-time Process |
S078 | 2018-03-16 | 30-day Notice |
S077 | 2017-12-21 | 30-day Notice |
S076 | 2017-11-28 | 30-day Notice |
S075 | 2017-11-21 | 30-day Notice |
S074 | 2017-11-13 | 30-day Notice |
S073 | 2017-10-17 | Real-time Process |
S072 | 2017-09-08 | 30-day Notice |
S071 | 2017-06-15 | 135 Review Track For 30-day Notice |
S070 | 2017-06-06 | Real-time Process |
S069 | 2017-04-06 | 30-day Notice |
S068 | 2017-01-23 | Normal 180 Day Track No User Fee |
S067 | 2016-12-23 | Real-time Process |
S066 | 2016-12-02 | Real-time Process |
S065 | 2016-11-30 | 30-day Notice |
S064 | 2016-07-29 | 135 Review Track For 30-day Notice |
S063 | 2016-04-08 | 30-day Notice |
S062 | ||
S061 | 2016-03-09 | 30-day Notice |
S060 | 2016-02-04 | 30-day Notice |
S059 | 2015-12-09 | 30-day Notice |
S058 | 2015-10-21 | Real-time Process |
S057 | ||
S056 | 2015-02-12 | 30-day Notice |
S055 | 2014-07-23 | 30-day Notice |
S054 | 2014-06-19 | 30-day Notice |
S053 | 2013-12-19 | 30-day Notice |
S052 | 2013-12-19 | 30-day Notice |
S051 | 2013-11-18 | 30-day Notice |
S050 | 2013-08-30 | Panel Track |
S049 | 2013-08-09 | Panel Track |
S048 | 2013-07-31 | Normal 180 Day Track |
S047 | 2013-04-22 | 30-day Notice |
S046 | 2013-03-20 | 30-day Notice |
S045 | 2012-12-26 | Normal 180 Day Track No User Fee |
S044 | 2012-12-20 | 30-day Notice |
S043 | 2012-10-01 | 30-day Notice |
S042 | 2012-05-25 | 30-day Notice |
S041 | 2012-03-12 | 30-day Notice |
S040 | 2012-02-13 | 30-day Notice |
S039 | 2012-01-17 | 30-day Notice |
S038 | 2011-09-06 | 30-day Notice |
S037 | 2011-09-02 | 30-day Notice |
S036 | 2011-09-01 | Real-time Process |
S035 | 2011-08-29 | 30-day Notice |
S034 | 2011-07-05 | 30-day Notice |
S033 | 2011-07-01 | 30-day Notice |
S032 | 2011-06-24 | 30-day Notice |
S031 | 2011-06-09 | 30-day Notice |
S030 | 2011-02-10 | 30-day Notice |
S029 | 2010-11-01 | Normal 180 Day Track No User Fee |
S028 | 2010-10-19 | 30-day Notice |
S027 | 2010-08-25 | 30-day Notice |
S026 | 2010-08-10 | 30-day Notice |
S025 | 2010-05-03 | 30-day Notice |
S024 | 2010-05-03 | 30-day Notice |
S023 | 2010-01-19 | 30-day Notice |
S022 | 2009-12-24 | 30-day Notice |
S021 | 2009-10-19 | 30-day Notice |
S020 | 2009-09-02 | 30-day Notice |
S019 | 2009-06-30 | 30-day Notice |
S018 | 2009-06-18 | 135 Review Track For 30-day Notice |
S017 | 2009-05-11 | 30-day Notice |
S016 | 2009-05-11 | 30-day Notice |
S015 | 2009-04-02 | Real-time Process |
S014 | 2009-03-09 | Normal 180 Day Track |
S013 | 2009-02-20 | 30-day Notice |
S012 | 2008-07-01 | Normal 180 Day Track |
S011 | 2008-06-30 | 30-day Notice |
S010 | 2008-04-15 | Normal 180 Day Track No User Fee |
S009 | 2008-03-17 | 30-day Notice |
S008 | 2008-01-15 | Real-time Process |
S007 | 2007-12-20 | 30-day Notice |
S006 | 2007-10-31 | 30-day Notice |
S005 | 2007-08-06 | Real-time Process |
S004 | 2007-04-10 | 135 Review Track For 30-day Notice |
S003 | 2006-10-31 | Real-time Process |
S002 | 2006-07-24 | 30-day Notice |
S001 | 2005-07-12 | Real-time Process |