Approval for a change in method of sterilization from 12/88 eto/freon mixture to 100% ethylene oxide for a 0. 75 ml fill volume of viscoat at alcon's puerto rico manufacturing facility.
| Device | VISCOAT(R) |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ALCON LABORATORIES |
| Date Received | 1996-12-04 |
| Decision Date | 1998-03-03 |
| PMA | P840064 |
| Supplement | S020 |
| 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 | Yes |
| Applicant Address | ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P840064 | | Original Filing |
| S078 |
2022-08-23 |
30-day Notice |
| S077 |
2022-08-17 |
30-day Notice |
| S076 |
2021-04-12 |
Normal 180 Day Track No User Fee |
| S075 |
2021-04-12 |
Normal 180 Day Track No User Fee |
| S074 |
2021-02-02 |
30-day Notice |
| S073 |
2020-10-05 |
30-day Notice |
| S072 |
2020-08-20 |
30-day Notice |
| S071 |
2020-03-09 |
30-day Notice |
| S070 |
2018-08-07 |
135 Review Track For 30-day Notice |
| S069 |
2018-06-01 |
30-day Notice |
| S068 |
2018-03-27 |
30-day Notice |
| S067 |
2017-10-18 |
30-day Notice |
| S066 |
2017-03-07 |
Real-time Process |
| S065 |
2017-02-15 |
30-day Notice |
| S064 |
2017-02-01 |
135 Review Track For 30-day Notice |
| S063 |
2016-10-24 |
30-day Notice |
| S062 |
2016-07-21 |
Normal 180 Day Track No User Fee |
| S061 |
2016-04-25 |
30-day Notice |
| S060 |
2015-05-13 |
30-day Notice |
| S059 |
2015-01-23 |
Normal 180 Day Track |
| S058 |
2014-11-12 |
30-day Notice |
| S057 |
2014-09-29 |
30-day Notice |
| S056 |
2014-04-02 |
30-day Notice |
| S055 |
2013-07-12 |
30-day Notice |
| S054 |
2013-06-28 |
30-day Notice |
| S053 |
2013-03-08 |
30-day Notice |
| S052 |
2012-11-13 |
30-day Notice |
| S051 |
2012-07-03 |
30-day Notice |
| S050 |
2012-02-14 |
30-day Notice |
| S049 |
2012-01-05 |
30-day Notice |
| S048 |
2012-01-05 |
30-day Notice |
| S047 |
2011-12-22 |
30-day Notice |
| S046 |
2011-04-19 |
30-day Notice |
| S045 |
2010-10-15 |
30-day Notice |
| S044 |
2010-09-20 |
135 Review Track For 30-day Notice |
| S043 |
2010-05-24 |
30-day Notice |
| S042 |
2010-05-24 |
30-day Notice |
| S041 |
2009-09-15 |
30-day Notice |
| S040 |
2009-02-20 |
135 Review Track For 30-day Notice |
| S039 |
2008-11-24 |
30-day Notice |
| S038 |
2008-10-31 |
135 Review Track For 30-day Notice |
| S037 |
2008-10-31 |
30-day Notice |
| S036 |
2008-10-09 |
Normal 180 Day Track No User Fee |
| S035 |
2008-04-08 |
30-day Notice |
| S034 |
2007-12-11 |
30-day Notice |
| S033 |
2007-11-14 |
30-day Notice |
| S032 |
2007-06-12 |
Normal 180 Day Track No User Fee |
| S031 |
2006-05-18 |
30-day Notice |
| S030 |
2005-12-05 |
30-day Notice |
| S029 |
2005-08-10 |
Real-time Process |
| S028 |
2005-07-06 |
30-day Notice |
| S027 |
2005-04-05 |
Real-time Process |
| S026 |
2004-06-21 |
Normal 180 Day Track |
| S025 |
2004-02-17 |
Real-time Process |
| S024 |
2003-04-24 |
Special (immediate Track) |
| S023 |
2002-02-20 |
Special (immediate Track) |
| S022 |
2000-12-15 |
Special (immediate Track) |
| S021 |
1998-03-23 |
Normal 180 Day Track |
| S020 |
1996-12-04 |
Normal 180 Day Track |
| S019 |
1996-12-04 |
Normal 180 Day Track |
| S018 | | |
| S017 |
1995-12-26 |
Normal 180 Day Track |
| S016 |
1995-09-22 |
Normal 180 Day Track |
| S015 |
1995-08-14 |
Normal 180 Day Track |
| S014 |
1995-05-30 |
Normal 180 Day Track |
| S013 | | |
| S012 |
1995-01-10 |
Normal 180 Day Track |
| S011 |
1993-12-28 |
Normal 180 Day Track |
| S010 |
1990-06-18 |
Normal 180 Day Track |
| S009 |
1990-03-16 |
Normal 180 Day Track |
| S008 |
1989-10-11 |
Normal 180 Day Track |
| S007 |
1989-08-23 |
Normal 180 Day Track |
| S006 |
1987-10-21 |
Normal 180 Day Track |
| S005 |
1987-08-21 |
Normal 180 Day Track |
| S004 |
1987-05-06 |
Normal 180 Day Track |
| S003 |
1987-03-05 |
Normal 180 Day Track |
| S002 |
1986-12-08 |
Normal 180 Day Track |
| S001 |
1986-12-05 |
Normal 180 Day Track |
NIH GUDID Devices