Lotrafilcon A and B Soft Contact Lenses

FDA Premarket Approval P010019 S083

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

DeviceLotrafilcon A and B Soft Contact Lenses
Generic NameLenses, Soft Contact, Extended Wear
ApplicantAlcon Laboratories, Inc.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP010019 Supplement NumberS083 Date Received06/09/2022 Decision Date07/06/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-09
Decision Date2022-07-06
PMAP010019
SupplementS083
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAlcon Laboratories, Inc.
6201 South Freeway
fort Worth, TX 76134-2099 PMA NumberP010019 Supplement NumberS083 Date Received06/09/2022 Decision Date07/06/2022 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  
adding An Alternate Supplier For The Primary Packaging Material Of Alcon Lotrafilcon A And B Soft Contact Lens Products

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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