This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | VISCOAT™ Ophthalmic Viscosurgical , DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™), |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ALCON LABORATORIES6201 S Freewayft Worth, TX 76134 PMA NumberP840064 Supplement NumberS077 Date Received08/17/2022 Decision Date09/13/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-17 |
| Decision Date | 2022-09-13 |
| PMA | P840064 |
| Supplement | S077 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | 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 PMA NumberP840064 Supplement NumberS077 Date Received08/17/2022 Decision Date09/13/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement a Change In The Maximum Ethylene Oxide (EO) Sterilization Process Parameter Specifications (without Change To The EO Sterilization Process Set Points Or Final Product Release Specifications) |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00380651839755 | P840064 | 001 |
| 00380651839052 | P840064 | 001 |
| 00380651837102 | P840064 | 026 |