This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | FLUOROPERM RGP CONTACT LENSES |
| Classification Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Generic Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Applicant | PARAGON VISION SCIENCES |
| Date Received | 1987-05-20 |
| Decision Date | 1987-12-31 |
| Notice Date | 1988-02-22 |
| PMA | P870024 |
| Supplement | S |
| Product Code | MWL |
| Docket Number | 88M-0013 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870024 | Original Filing | |
| S062 | 2022-04-15 | 30-day Notice |
| S061 | ||
| S060 | ||
| S059 | ||
| S058 | 2021-01-21 | Normal 180 Day Track No User Fee |
| S057 | 2020-08-05 | 30-day Notice |
| S056 | 2020-08-04 | 30-day Notice |
| S055 | 2020-07-23 | 30-day Notice |
| S054 | 2020-07-22 | 30-day Notice |
| S053 | 2020-03-26 | 30-day Notice |
| S052 | 2019-06-07 | 30-day Notice |
| S051 | ||
| S050 | ||
| S049 | 2010-10-25 | Normal 180 Day Track No User Fee |
| S048 | ||
| S047 | 2009-06-17 | Normal 180 Day Track |
| S046 | 2009-03-30 | 30-day Notice |
| S045 | 2004-12-15 | 30-day Notice |
| S044 | 2004-08-31 | 30-day Notice |
| S043 | 2001-10-02 | Panel Track |
| S042 | 1999-07-12 | Normal 180 Day Track |
| S041 | 1997-05-12 | Normal 180 Day Track |
| S040 | 1993-11-12 | Normal 180 Day Track |
| S039 | 1993-11-12 | Normal 180 Day Track |
| S038 | 1993-03-24 | Normal 180 Day Track |
| S037 | 1993-01-28 | Normal 180 Day Track |
| S036 | 1992-11-18 | Normal 180 Day Track |
| S035 | 1992-11-12 | Normal 180 Day Track |
| S034 | 1992-10-20 | Normal 180 Day Track |
| S033 | 1992-06-18 | Normal 180 Day Track |
| S032 | 1992-02-20 | Normal 180 Day Track |
| S031 | 1992-01-27 | Normal 180 Day Track |
| S030 | 1991-11-12 | Normal 180 Day Track |
| S029 | 1991-11-06 | Normal 180 Day Track |
| S028 | ||
| S027 | 1991-09-19 | Normal 180 Day Track |
| S026 | 1991-07-31 | Normal 180 Day Track |
| S025 | 1991-04-18 | Normal 180 Day Track |
| S024 | 1990-12-06 | 30-Day Supplement |
| S023 | 1990-10-17 | Normal 180 Day Track |
| S022 | 1990-10-05 | Normal 180 Day Track |
| S021 | ||
| S020 | 1990-06-20 | 30-Day Supplement |
| S019 | 1990-05-21 | Normal 180 Day Track |
| S018 | 1990-04-18 | 30-Day Supplement |
| S017 | 1990-03-14 | 30-Day Supplement |
| S016 | 1990-02-12 | Normal 180 Day Track |
| S015 | 1989-12-26 | Normal 180 Day Track |
| S014 | 1989-10-11 | Normal 180 Day Track |
| S013 | 1989-08-02 | Normal 180 Day Track |
| S012 | 1989-07-24 | Normal 180 Day Track |
| S011 | 1989-06-05 | Normal 180 Day Track |
| S010 | 1989-05-26 | Normal 180 Day Track |
| S009 | 1989-05-15 | Normal 180 Day Track |
| S008 | 1989-04-12 | Normal 180 Day Track |
| S007 | 1989-01-18 | Normal 180 Day Track |
| S006 | ||
| S005 | 1988-08-17 | Normal 180 Day Track |
| S004 | 1988-05-17 | Normal 180 Day Track |
| S003 | 1988-05-17 | Normal 180 Day Track |
| S002 | 1988-03-09 | Panel Track |
| S001 | 1987-11-25 | Normal 180 Day Track |