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.
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.
| Device | ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| Date Received | 1997-07-03 |
| Decision Date | 1997-07-11 |
| PMA | N18033 |
| Supplement | S031 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 Centurion Pkwy. jacksonville, FL 32256 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N18033 | Original 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 |