Approval for a different release agent to be used with their existing petg material in the outer blister tray for the secondary packaging of all of the healon ophthalmic viscoelastic products. The device, as modified, will be marketed under the trade names: healon, healon gv and healon5 sodium hyaluronate and is intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
| Device | HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2006-12-11 |
| Decision Date | 2007-08-30 |
| PMA | P810031 |
| Supplement | S033 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | 135 Review Track For 30-day Notice |
| 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 |
Supplemental Filings
| 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 |
|
NIH GUDID Devices