Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

FDA Premarket Approval P080011 S113

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.

Pre-market Approval Supplement Details

Introduction of a new order management and dispatch software system for the biofinity lathing products at the coopervision manufacturing ltd. Facility in hamble, uk.

DeviceBiofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCooperVision, Inc.
Date Received2020-07-30
Decision Date2020-08-27
PMAP080011
SupplementS113
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 san Ramon, CA 94583

Supplemental Filings

Supplement NumberDateSupplement Type
P080011Original Filing
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

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