ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval N18033 S031

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

Approval for changes in the package insert and fitting and patient management guide pertaining to the acuvue(r) bifocal (etafilcon a) contact lens. The changes are designed to enhance practitioners' fitting performance and early visual success of the patient. No changes are made tot he remaining portions of approved labeling.

DeviceACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantVISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
Date Received1997-07-03
Decision Date1997-07-11
PMAN18033
SupplementS031
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 Centurion Pkwy. jacksonville, FL 32256

Supplemental Filings

Supplement NumberDateSupplement Type
N18033Original Filing
S110 2022-11-21 30-day Notice
S109 2022-06-24 Normal 180 Day Track
S108 2020-10-29 30-day Notice
S107 2020-05-05 30-day Notice
S106
S105 2019-05-14 30-day Notice
S104 2019-05-03 30-day Notice
S103 2019-04-25 30-day Notice
S102 2019-03-28 30-day Notice
S101
S100 2018-09-04 30-day Notice
S099 2018-06-18 30-day Notice
S098 2018-04-30 30-day Notice
S097 2018-02-12 30-day Notice
S096 2017-10-17 30-day Notice
S095 2017-09-27 30-day Notice
S094 2017-08-01 30-day Notice
S093 2017-07-03 30-day Notice
S092 2017-05-24 30-day Notice
S091 2017-04-14 30-day Notice
S090 2017-04-10 30-day Notice
S089 2017-03-27 30-day Notice
S088 2017-02-06 30-day Notice
S087 2017-01-27 30-day Notice
S086 2017-01-17 30-day Notice
S085 2016-12-20 30-day Notice
S084 2016-11-01 30-day Notice
S083 2016-07-15 30-day Notice
S082 2016-07-13 Special (immediate Track)
S081 2016-04-11 30-day Notice
S080 2016-02-08 30-day Notice
S079 2015-09-21 30-day Notice
S078
S077 2015-04-09 30-day Notice
S076 2015-04-03 30-day Notice
S075 2014-12-23 30-day Notice
S074 2014-07-15 30-day Notice
S073 2013-07-26 30-day Notice
S072 2013-04-02 30-day Notice
S071
S070 2013-02-13 30-day Notice
S069 2013-02-05 30-day Notice
S068 2013-01-28 30-day Notice
S067 2012-11-13 30-day Notice
S066 2012-07-06 30-day Notice
S065 2012-04-12 30-day Notice
S064 2012-02-28 30-day Notice
S063 2011-11-23 30-day Notice
S062 2011-11-07 30-day Notice
S061 2011-09-19 135 Review Track For 30-day Notice
S060 2011-08-15 30-day Notice
S059 2011-05-23 30-day Notice
S058 2011-05-17 30-day Notice
S057 2011-05-16 30-day Notice
S056 2011-05-12 30-day Notice
S055 2011-04-22 30-day Notice
S054 2011-03-10 30-day Notice
S053 2011-01-18 30-day Notice
S052 2011-01-18 30-day Notice
S051
S050 2010-10-08 30-day Notice
S049 2010-10-01 30-day Notice
S048 2010-09-29 135 Review Track For 30-day Notice
S047 2010-06-28 30-day Notice
S046 2010-04-02 30-day Notice
S045 2010-03-10 135 Review Track For 30-day Notice
S044 2010-03-08 135 Review Track For 30-day Notice
S043 2009-09-23 30-day Notice
S042 2009-06-22 Real-time Process
S041 2009-04-20 30-day Notice
S040 2006-09-05 Real-time Process
S039 2003-12-22 Real-time Process
S038 2002-12-16 Real-time Process
S037 2002-02-19 Special (immediate Track)
S036 2001-06-29 Real-time Process
S035 2001-01-29 Normal 180 Day Track
S034 2000-11-03 Normal 180 Day Track
S033 1999-04-01 Real-time Process
S032 1999-03-01 Real-time Process
S031 1997-07-03 Real-time Process
S030 1997-05-02 Real-time Process
S029 1996-07-18 Normal 180 Day Track
S028 1996-02-06 Normal 180 Day Track
S027 1993-05-14 Normal 180 Day Track
S026 1992-10-16 Normal 180 Day Track
S025 1990-09-21 Normal 180 Day Track
S024 1990-06-05 Normal 180 Day Track
S023
S022 1989-07-20 Normal 180 Day Track
S021 1989-07-20 Normal 180 Day Track
S020 1989-07-20 Normal 180 Day Track
S019 1988-03-14 Normal 180 Day Track
S018 1987-09-15 Special (immediate Track)
S017 1987-09-16 Special (immediate Track)
S016 1987-05-18 Normal 180 Day Track
S015 1986-07-23 Normal 180 Day Track
S014 1986-03-26
S013 1985-09-11
S012
S011 1985-02-25
S010 1984-12-10
S009 1983-12-21
S008 1983-07-15
S007 1983-03-24
S006 1982-12-27
S005 1982-07-07
S004 1982-04-08
S003 1981-03-05
S002
S001 1979-08-28

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