Approval for the following:1. Change in the derivation process of the sodium hyaluronate (ha), which is the rheological active component in the above-mentioned ovds, from rooster comb derivation to bacterial fermentation;2. Change in the supplier of the ha raw material from amo uppsala to htl s. A. S. (paris, france);3. Change in the composition and supplier of the buffer solution, which is used to reconstitute the dried ha into its final intended form;4. Change in the buffer solution supplier from fresenius kabi norway as (halden, norway) to biochrom gmbh (berlin, germany);5. Change in the silicone emulsion supplier used to siliconize the inner glass cylinder from tribotec ab (möinlycke, sweden) to bisterfeld spezialchemie gmbh (hamburg, germany); and6. Minor changes to the primary packaging components: a. Change in the rubber used in the subject devices’ plunger and aluminum cap from chlorobutyl rubber supplied by west pharmaceutical services, inc. (eschweiler, de) to bromobutyl rubber supplied by datwyler pharma packaging international (alken, belgium); and b. Reduction in the dimensions of the inner diameter and head height of the glass cylinder.
Device | Sodium Hyaluronate Ophtalmic Viscoelastc s (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack |
Applicant | Johnson & Johnson Surgical Vision, Inc. |
Date Received | 2017-10-30 |
Decision Date | 2018-01-26 |
PMA | P810031 |
Supplement | S063 |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
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