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.
The 30-day notice requested introduction of a manufacturing process change for the polymacon contact lenses for extended wear. The requested change will allow the lenses to be manufactured using an alternate polyvinyl chloride resin mold material. The manufacturing process and procedures will not change.
| Device | BAUSCH AND LOMB POLYMACON CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 1999-10-26 |
| Decision Date | 1999-11-02 |
| PMA | N16895 |
| Supplement | S086 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N16895 | Original Filing | |
| S105 | 2022-02-18 | 30-day Notice |
| S104 | ||
| S103 | 2020-03-20 | 30-day Notice |
| S102 | 2018-07-05 | 30-day Notice |
| S101 | 2018-05-15 | 30-day Notice |
| S100 | 2017-07-14 | 30-day Notice |
| S099 | 2016-07-21 | Real-time Process |
| S098 | 2016-07-15 | 30-day Notice |
| S097 | 2015-08-03 | 30-day Notice |
| S096 | 2014-09-02 | 30-day Notice |
| S095 | 2014-01-03 | 135 Review Track For 30-day Notice |
| S094 | 2011-10-19 | 135 Review Track For 30-day Notice |
| S093 | 2011-02-08 | 30-day Notice |
| S092 | 2011-01-10 | 30-day Notice |
| S091 | 2008-11-12 | Real-time Process |
| S090 | 2008-09-24 | Real-time Process |
| S089 | 2005-10-18 | Normal 180 Day Track No User Fee |
| S088 | 2001-01-09 | Normal 180 Day Track |
| S087 | 1999-11-16 | Normal 180 Day Track |
| S086 | 1999-10-26 | 30-day Notice |
| S085 | 1997-08-07 | Normal 180 Day Track |
| S084 | 1996-10-01 | Normal 180 Day Track |
| S083 | 1994-11-18 | Normal 180 Day Track |
| S082 | 1993-08-12 | Normal 180 Day Track |
| S081 | 1992-12-01 | Normal 180 Day Track |
| S080 | 1991-11-18 | Normal 180 Day Track |
| S079 | 1991-08-27 | Normal 180 Day Track |
| S078 | ||
| S077 | 1991-06-18 | Normal 180 Day Track |
| S076 | 1991-06-05 | Normal 180 Day Track |
| S075 | 1991-05-10 | Normal 180 Day Track |
| S074 | 1991-05-02 | Normal 180 Day Track |
| S073 | ||
| S072 | ||
| S071 | 1990-11-05 | Normal 180 Day Track |
| S070 | 1990-11-05 | Normal 180 Day Track |
| S069 | 1990-08-23 | Normal 180 Day Track |
| S068 | 1990-07-03 | Normal 180 Day Track |
| S067 | 1990-03-08 | Normal 180 Day Track |
| S066 | 1989-08-29 | Normal 180 Day Track |
| S065 | ||
| S064 | 1989-08-28 | Normal 180 Day Track |
| S063 | 1989-07-24 | Normal 180 Day Track |
| S062 | 1989-07-24 | Normal 180 Day Track |
| S061 | 1989-07-21 | Normal 180 Day Track |
| S060 | 1989-05-25 | Normal 180 Day Track |
| S059 | 1989-01-03 | Normal 180 Day Track |
| S058 | 1988-12-09 | Normal 180 Day Track |
| S057 | 1988-12-09 | Normal 180 Day Track |
| S056 | 1988-12-08 | Normal 180 Day Track |
| S055 | 1988-12-06 | Normal 180 Day Track |
| S054 | 1988-09-20 | Normal 180 Day Track |
| S053 | 1988-08-05 | Special (immediate Track) |
| S052 | 1988-07-29 | Normal 180 Day Track |
| S051 | 1987-10-15 | Normal 180 Day Track |
| S050 | 1987-09-02 | Normal 180 Day Track |
| S049 | 1987-08-06 | 30-Day Supplement |
| S048 | 1987-05-15 | Normal 180 Day Track |
| S047 | 1987-02-02 | 30-Day Supplement |
| S046 | 1987-01-21 | Normal 180 Day Track |
| S045 | 1987-01-05 | Normal 180 Day Track |
| S044 | 1986-08-20 | Normal 180 Day Track |
| S043 | 1986-04-22 | |
| S042 | 1986-03-18 | Normal 180 Day Track |
| S041 | 1986-03-18 | |
| S040 | 1985-08-30 | |
| S039 | ||
| S038 | 1985-03-20 | |
| S037 | 1985-02-07 | |
| S036 | 1984-07-23 | |
| S035 | ||
| S034 | ||
| S033 | 1984-06-22 | |
| S032 | ||
| S031 | 1984-05-08 | |
| S030 | ||
| S029 | 1983-11-14 | |
| S028 | 1983-04-13 | |
| S027 | 1982-12-27 | |
| S026 | 1982-12-16 | |
| S025 | 1982-08-25 | |
| S024 | 1982-07-20 | |
| S023 | 1982-05-20 | |
| S022 | ||
| S021 | 1982-02-19 | |
| S020 | 1981-12-17 | |
| S019 | 1981-10-19 | |
| S018 | 1981-07-29 | |
| S017 | 1981-05-05 | |
| S016 | ||
| S015 | 1980-12-30 | |
| S014 | 1980-09-26 | |
| S013 | 1980-08-25 | |
| S012 | 1980-08-25 | |
| S011 | 1980-08-15 | |
| S010 | 1980-08-01 | |
| S009 | 1980-05-05 | |
| S008 | 1980-04-21 | |
| S007 | 1980-02-05 | |
| S006 | 1979-08-02 | |
| S005 | 1979-07-13 | |
| S004 | 1979-06-06 | |
| S003 | 1979-02-15 | |
| S002 | 1978-12-11 | |
| S001 | 1979-03-02 | Normal 180 Day Track |