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 | Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Energys, Biofinity Multifoca |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS140 Date Received03/17/2022 Decision Date04/14/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-17 |
| Decision Date | 2022-04-14 |
| PMA | P080011 |
| Supplement | S140 |
| 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 PMA NumberP080011 Supplement NumberS140 Date Received03/17/2022 Decision Date04/14/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement updates To The Software Used In The Wet Automated Inspection System For The Biofinity Automated Wet Lines At The CooperVision Manufacturing Facility In Hamble UK |
| 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 |