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 adding the manufacturing facility at vistakon, johnson & johnson (ireland) lte. , limerick, ireland, for the manufacture of accuvue(r) (etafilcon a) extended wear contact lenses.
| Device | ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| Date Received | 2000-11-03 |
| Decision Date | 2001-05-18 |
| PMA | N18033 |
| Supplement | S034 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| 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 |