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.
| Device | HEALON |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 1987-08-13 |
| Decision Date | 1987-08-27 |
| PMA | P810031 |
| Supplement | S010 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |