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.
Approval is for wet shipping and up to 30 day storage of the extended wear rigid gas permeable lenses in alcon wetting, soakig, conditioning and disinfecting solution id 84392.
| Device | VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B) |
| Classification Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Generic Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Applicant | PARAGON VISION SCIENCES |
| Date Received | 1999-07-12 |
| Decision Date | 2000-01-31 |
| PMA | P870024 |
| Supplement | S042 |
| Product Code | MWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |