Approval for the use of alcon ireland cork (aic) as an alternative supplier of the cannula component to be used as part of the finished ophthalmic viscosurgical devices (ovds) at alcon-couvreur (purrs) manufacturing facility.
| Device | OPHTHALMIC VICOSURGICAL DEVICE (OVD) |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ALCON LABORATORIES |
| Date Received | 2017-02-01 |
| Decision Date | 2017-10-25 |
| PMA | P840064 |
| Supplement | S064 |
| 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 | 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