This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 1981-07-07 |
| Decision Date | 1983-01-14 |
| Notice Date | 1983-02-08 |
| PMA | P810031 |
| Supplement | S |
| Product Code | LZP |
| Docket Number | 83M-0022 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810031 | Original Filing | |
| S072 | 2021-06-02 | 30-day Notice |
| S071 | ||
| S070 | ||
| S069 | 2020-11-27 | 30-day Notice |
| S068 | 2020-10-01 | 30-day Notice |
| S067 | 2020-04-29 | 30-day Notice |
| S066 | ||
| S065 | 2018-12-03 | Normal 180 Day Track |
| S064 | 2018-02-02 | 30-day Notice |
| S063 | 2017-10-30 | Normal 180 Day Track |
| S062 | 2017-06-26 | 30-day Notice |
| S061 | 2016-11-16 | 30-day Notice |
| S060 | ||
| S059 | 2016-11-14 | Normal 180 Day Track No User Fee |
| S058 | 2016-08-01 | Real-time Process |
| S057 | 2016-06-10 | 30-day Notice |
| S056 | 2015-12-17 | Normal 180 Day Track |
| S055 | 2015-11-25 | Special (immediate Track) |
| S054 | 2015-06-11 | Normal 180 Day Track |
| S053 | 2015-06-03 | 30-day Notice |
| S052 | 2015-02-18 | 30-day Notice |
| S051 | 2014-08-29 | 30-day Notice |
| S050 | 2013-07-19 | 30-day Notice |
| S049 | 2013-07-01 | 30-day Notice |
| S048 | 2013-05-28 | 30-day Notice |
| S047 | 2013-03-15 | 30-day Notice |
| S046 | 2012-10-22 | Real-time Process |
| S045 | 2012-07-02 | 30-day Notice |
| S044 | 2012-03-30 | 30-day Notice |
| S043 | 2012-01-17 | 30-day Notice |
| S042 | 2012-01-04 | 30-day Notice |
| S041 | 2011-10-07 | 30-day Notice |
| S040 | 2011-08-01 | 30-day Notice |
| S039 | 2011-06-23 | 30-day Notice |
| S038 | 2010-09-03 | Normal 180 Day Track No User Fee |
| S037 | 2010-04-13 | Real-time Process |
| S036 | 2008-08-20 | 30-day Notice |
| S035 | 2008-01-18 | Normal 180 Day Track No User Fee |
| S034 | 2007-05-07 | 30-day Notice |
| S033 | 2006-12-11 | 135 Review Track For 30-day Notice |
| S032 | 2006-11-01 | 30-day Notice |
| S031 | 2006-09-29 | Normal 180 Day Track No User Fee |
| S030 | 2006-08-14 | 30-day Notice |
| S029 | 2006-08-14 | 30-day Notice |
| S028 | 2006-08-14 | 30-day Notice |
| S027 | 2006-04-13 | Real-time Process |
| S026 | 2005-02-08 | 30-day Notice |
| S025 | 2003-11-14 | 30-day Notice |
| S024 | 2002-07-10 | Special (immediate Track) |
| S023 | 2000-05-12 | Normal 180 Day Track |
| S022 | 1999-09-20 | Normal 180 Day Track |
| S021 | ||
| S020 | ||
| S019 | 1994-10-07 | Normal 180 Day Track |
| S018 | 1994-10-03 | Normal 180 Day Track |
| S017 | 1994-02-23 | Normal 180 Day Track |
| S016 | ||
| S015 | ||
| S014 | 1990-07-05 | Normal 180 Day Track |
| S013 | 1989-04-24 | Normal 180 Day Track |
| S012 | 1988-11-22 | Normal 180 Day Track |
| S011 | 1988-06-01 | Normal 180 Day Track |
| S010 | 1987-08-13 | Normal 180 Day Track |
| S009 | ||
| S008 | 1986-06-03 | Normal 180 Day Track |
| S007 | 1985-11-07 | |
| S006 | 1984-09-17 | |
| S005 | 1984-02-23 | |
| S004 | 1984-02-10 | |
| S003 | ||
| S002 | 1984-01-27 | |
| S001 | 1983-08-31 |
| Device ID | PMA | Supp |
|---|---|---|
| 05050474651425 | P810031 | 063 |
| 05050474636996 | P810031 | 063 |
| 05050474636989 | P810031 | 063 |
| 05050474636972 | P810031 | 063 |
| 05050474651654 | P810031 | 065 |