FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P010019 S049

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

Moving the 'lens rinsing' step from after the 100% wet lens qa inspection to before the inspection.

DeviceFOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantAlcon Laboratories, Inc.
Date Received2016-03-11
Decision Date2016-03-30
PMAP010019
SupplementS049
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099

Supplemental Filings

Supplement NumberDateSupplement Type
P010019Original 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

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