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.
The modification in the packaging sampling plan and qa final audit inspection regime performed post-autoclave for the biofinity products
| Device | Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CooperVision, Inc. |
| Date Received | 2021-03-24 |
| Decision Date | 2021-04-22 |
| PMA | P080011 |
| Supplement | S126 |
| 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 | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 san Ramon, CA 94583 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080011 | Original Filing | |
| S153 | 2022-12-21 | 30-day Notice |
| S152 | 2022-11-29 | 30-day Notice |
| S151 | 2022-11-09 | 30-day Notice |
| S150 | 2022-10-25 | 30-day Notice |
| S149 | 2022-09-30 | 30-day Notice |
| S148 | 2022-07-21 | 30-day Notice |
| S147 | 2022-07-11 | 30-day Notice |
| S146 | 2022-04-27 | Real-time Process |
| S145 | 2022-04-06 | 30-day Notice |
| S144 | ||
| S143 | 2022-03-31 | 30-day Notice |
| S142 | ||
| S141 | ||
| S140 | 2022-03-17 | 30-day Notice |
| S139 | ||
| S138 | 2022-01-19 | 30-day Notice |
| S137 | 2021-12-09 | 30-day Notice |
| S136 | 2021-11-15 | 30-day Notice |
| S135 | ||
| S134 | 2021-10-28 | 30-day Notice |
| S133 | 2021-10-21 | 30-day Notice |
| S132 | 2021-10-13 | 30-day Notice |
| S131 | ||
| S130 | ||
| S129 | 2021-05-12 | 30-day Notice |
| S128 | 2021-04-26 | 30-day Notice |
| S127 | 2021-04-09 | 30-day Notice |
| S126 | 2021-03-24 | 30-day Notice |
| S125 | 2021-03-18 | 30-day Notice |
| S124 | 2021-03-11 | 30-day Notice |
| S123 | 2021-02-04 | 30-day Notice |
| S122 | 2020-12-28 | 30-day Notice |
| S121 | 2020-12-14 | 30-day Notice |
| S120 | ||
| S119 | 2020-10-20 | 30-day Notice |
| S118 | 2020-10-09 | 30-day Notice |
| S117 | 2020-09-10 | 30-day Notice |
| S116 | 2020-08-24 | 30-day Notice |
| S115 | 2020-08-20 | 30-day Notice |
| S114 | 2020-08-10 | 30-day Notice |
| S113 | 2020-07-30 | 30-day Notice |
| S112 | ||
| S111 | 2020-07-17 | 30-day Notice |
| S110 | ||
| S109 | 2020-07-14 | 30-day Notice |
| S108 | 2020-07-01 | 30-day Notice |
| S107 | 2020-06-29 | 30-day Notice |
| S106 | ||
| S105 | 2020-03-24 | 30-day Notice |
| S104 | 2020-03-04 | 30-day Notice |
| S103 | 2020-02-26 | 30-day Notice |
| S102 | 2020-02-13 | 30-day Notice |
| S101 | ||
| S100 | 2019-09-30 | Normal 180 Day Track |
| S099 | 2019-09-17 | 30-day Notice |
| S098 | ||
| S097 | 2019-08-13 | 30-day Notice |
| S096 | 2019-08-09 | 30-day Notice |
| S095 | 2019-07-12 | 30-day Notice |
| S094 | 2019-05-13 | 30-day Notice |
| S093 | 2019-05-02 | 30-day Notice |
| S092 | 2019-04-16 | 30-day Notice |
| S091 | 2019-03-11 | 30-day Notice |
| S090 | 2019-02-01 | 30-day Notice |
| S089 | 2019-01-10 | 30-day Notice |
| S088 | 2019-01-03 | 30-day Notice |
| S087 | ||
| S086 | 2018-12-17 | 30-day Notice |
| S085 | ||
| S084 | 2018-11-09 | 30-day Notice |
| S083 | 2018-11-01 | 30-day Notice |
| S082 | 2018-10-19 | Normal 180 Day Track No User Fee |
| S081 | 2018-09-25 | 30-day Notice |
| S080 | 2018-08-10 | 30-day Notice |
| S079 | 2018-08-09 | Normal 180 Day Track No User Fee |
| S078 | 2018-07-19 | 30-day Notice |
| S077 | 2018-07-12 | 30-day Notice |
| S076 | 2018-06-11 | 30-day Notice |
| S075 | 2018-05-09 | 30-day Notice |
| S074 | 2018-03-16 | 135 Review Track For 30-day Notice |
| S073 | 2018-03-14 | 30-day Notice |
| S072 | 2018-02-27 | 30-day Notice |
| S071 | 2018-02-14 | 30-day Notice |
| S070 | 2018-01-29 | 30-day Notice |
| S069 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S068 | 2018-01-11 | Normal 180 Day Track No User Fee |
| S067 | 2017-12-26 | Normal 180 Day Track No User Fee |
| S066 | 2017-12-19 | Normal 180 Day Track No User Fee |
| S065 | 2017-12-04 | 30-day Notice |
| S064 | 2017-11-17 | 30-day Notice |
| S063 | 2017-10-26 | 30-day Notice |
| S062 | 2017-10-23 | 30-day Notice |
| S061 | 2017-07-14 | 30-day Notice |
| S060 | 2017-05-26 | 30-day Notice |
| S059 | 2017-05-16 | 30-day Notice |
| S058 | 2017-03-27 | Normal 180 Day Track No User Fee |
| S057 | 2017-03-24 | 30-day Notice |
| S056 | 2017-03-13 | 30-day Notice |
| S055 | 2017-02-02 | 30-day Notice |
| S054 | 2017-01-10 | 30-day Notice |
| S053 | 2017-01-08 | 30-day Notice |
| S052 | 2016-12-06 | 30-day Notice |
| S051 | 2016-11-03 | 30-day Notice |
| S050 | 2016-10-13 | 30-day Notice |
| S049 | 2016-09-27 | Normal 180 Day Track No User Fee |
| S048 | 2016-09-19 | 30-day Notice |
| S047 | 2016-09-19 | 30-day Notice |
| S046 | 2016-09-13 | 30-day Notice |
| S045 | 2016-05-16 | 30-day Notice |
| S044 | 2016-05-16 | 30-day Notice |
| S043 | ||
| S042 | 2016-03-14 | 30-day Notice |
| S041 | 2016-02-29 | 30-day Notice |
| S040 | 2015-10-09 | 30-day Notice |
| S039 | 2015-10-07 | 30-day Notice |
| S038 | 2015-07-02 | 30-day Notice |
| S037 | 2015-04-14 | 30-day Notice |
| S036 | 2015-03-12 | 30-day Notice |
| S035 | 2014-12-16 | Normal 180 Day Track |
| S034 | 2014-12-15 | 30-day Notice |
| S033 | 2014-11-28 | 30-day Notice |
| S032 | 2014-11-03 | 30-day Notice |
| S031 | 2014-08-08 | 30-day Notice |
| S030 | 2014-02-27 | 135 Review Track For 30-day Notice |
| S029 | 2014-02-03 | Normal 180 Day Track No User Fee |
| S028 | 2013-11-13 | 135 Review Track For 30-day Notice |
| S027 | 2013-08-12 | 30-day Notice |
| S026 | 2013-07-03 | 30-day Notice |
| S025 | 2013-07-01 | 30-day Notice |
| S024 | 2013-05-13 | Normal 180 Day Track No User Fee |
| S023 | 2013-04-09 | 30-day Notice |
| S022 | 2012-12-20 | 30-day Notice |
| S021 | 2012-12-19 | 30-day Notice |
| S020 | 2012-12-12 | 30-day Notice |
| S019 | 2012-11-07 | 30-day Notice |
| S018 | 2012-09-17 | Normal 180 Day Track No User Fee |
| S017 | 2012-08-28 | 30-day Notice |
| S016 | 2012-06-25 | 30-day Notice |
| S015 | 2012-06-21 | Normal 180 Day Track No User Fee |
| S014 | 2012-06-15 | 30-day Notice |
| S013 | 2012-06-05 | 30-day Notice |
| S012 | 2012-05-22 | 30-day Notice |
| S011 | 2012-03-30 | 30-day Notice |
| S010 | 2012-02-01 | 30-day Notice |
| S009 | 2012-01-26 | Special (immediate Track) |
| S008 | 2012-01-24 | 30-day Notice |
| S007 | 2012-01-24 | 30-day Notice |
| S006 | 2011-11-01 | 30-day Notice |
| S005 | 2011-08-11 | Normal 180 Day Track No User Fee |
| S004 | 2011-02-24 | Normal 180 Day Track No User Fee |
| S003 | 2010-03-12 | 30-day Notice |
| S002 | 2010-01-19 | 30-day Notice |
| S001 | 2009-02-27 | 30-day Notice |