Approval for the transfer and expansion of the quality control microbiology laboratory used for the healon, healon gv and healon5 sodium hyaluronate ophthalmic viscoelastic devices. The transfer includes test methods, personnel, and equipment from building 16 to building 23 located in uppsala, sweden.
| Device | HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2006-09-29 |
| Decision Date | 2007-08-16 |
| PMA | P810031 |
| Supplement | S031 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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