New analytical method for residual solvents.
Device | PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD) |
Generic Name | Aid, Surgical, Viscoelastic |
Applicant | Alcon Research, Ltd. |
Date Received | 2012-01-05 |
Decision Date | 2012-02-01 |
PMA | P890047 |
Supplement | S037 |
Product Code | LZP |
Advisory Committee | Ophthalmic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Alcon Research, Ltd. 6201 South Freeway, R3-48 fort Worth, TX 76134-2099 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P890047 | | Original Filing |
S059 |
2022-08-23 |
30-day Notice |
S058 |
2022-08-17 |
30-day Notice |
S057 |
2021-02-02 |
30-day Notice |
S056 |
2020-10-05 |
30-day Notice |
S055 |
2020-08-20 |
30-day Notice |
S054 |
2020-03-09 |
30-day Notice |
S053 |
2018-03-27 |
30-day Notice |
S052 |
2017-10-18 |
30-day Notice |
S051 |
2017-03-07 |
Real-time Process |
S050 |
2017-02-15 |
30-day Notice |
S049 |
2017-02-01 |
135 Review Track For 30-day Notice |
S048 |
2016-07-21 |
Normal 180 Day Track No User Fee |
S047 |
2016-04-25 |
30-day Notice |
S046 |
2015-05-13 |
30-day Notice |
S045 |
2014-11-12 |
30-day Notice |
S044 |
2014-09-29 |
30-day Notice |
S043 |
2014-04-02 |
30-day Notice |
S042 |
2013-08-16 |
Normal 180 Day Track |
S041 |
2013-07-12 |
30-day Notice |
S040 |
2013-03-08 |
30-day Notice |
S039 |
2012-07-03 |
30-day Notice |
S038 |
2012-02-14 |
30-day Notice |
S037 |
2012-01-05 |
30-day Notice |
S036 |
2012-01-05 |
30-day Notice |
S035 |
2011-12-22 |
30-day Notice |
S034 |
2011-04-19 |
30-day Notice |
S033 |
2010-10-15 |
30-day Notice |
S032 |
2010-09-20 |
135 Review Track For 30-day Notice |
S031 |
2010-05-24 |
30-day Notice |
S030 |
2010-05-24 |
30-day Notice |
S029 |
2009-09-15 |
30-day Notice |
S028 |
2009-02-20 |
135 Review Track For 30-day Notice |
S027 |
2008-11-24 |
30-day Notice |
S026 |
2008-10-31 |
135 Review Track For 30-day Notice |
S025 |
2008-10-31 |
30-day Notice |
S024 |
2008-10-09 |
Normal 180 Day Track No User Fee |
S023 |
2008-04-08 |
30-day Notice |
S022 |
2007-12-26 |
Normal 180 Day Track |
S021 |
2007-12-11 |
30-day Notice |
S020 |
2007-11-14 |
30-day Notice |
S019 |
2007-06-12 |
Normal 180 Day Track No User Fee |
S018 |
2006-05-18 |
30-day Notice |
S017 |
2005-07-06 |
30-day Notice |
S016 |
2004-02-17 |
Real-time Process |
S015 |
2003-04-24 |
Special (immediate Track) |
S014 |
2002-02-20 |
Special (immediate Track) |
S013 |
2000-12-15 |
Special (immediate Track) |
S012 | | |
S011 |
1996-12-04 |
Normal 180 Day Track |
S010 |
1995-12-27 |
Normal 180 Day Track |
S009 |
1995-09-22 |
Normal 180 Day Track |
S008 |
1995-08-14 |
Normal 180 Day Track |
S007 |
1995-05-30 |
Normal 180 Day Track |
S006 | | |
S005 |
1995-01-10 |
Normal 180 Day Track |
S004 |
1994-06-02 |
Normal 180 Day Track |
S003 |
1994-05-12 |
Normal 180 Day Track |
S002 |
1993-12-28 |
Normal 180 Day Track |
S001 |
1992-11-17 |
Normal 180 Day Track |
NIH GUDID Devices