Approval for a new secondary carton package containing one heaton ovd (0. 55 ml) and one heaton® endocoat ovd (0. 85 ml). The device, as modified, will be marketed under the trade name heaton duet dual pack and is indicated for: healon:heaton® ovd is intended for use as a surgical aid in cataract extraction (intra- and extracapsular), iol implantation, corneal transplant, glaucoma filtration and retinal attachment surgery. Heaton endocoat:heaton® endocoat ovd, model vt585 is intended for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: 1) cataract surgery with an intraocular lens; 2) cataract surgery without an intraocular lens; and 3) secondary intraocular lens implantation. Heaton® endocoat ovd maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamberduring surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.
| Device | HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3 |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2012-10-22 |
| Decision Date | 2013-01-11 |
| PMA | P810031 |
| Supplement | S046 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| 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