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.
Modification of a specific process of manufacture to reduce the hydration time and improve the comfort for the contact lens user.
| Device | PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES |
| Classification Name | Lens, Contact (orthokeratology) |
| Generic Name | Lens, Contact (orthokeratology) |
| Applicant | PARAGON VISION SCIENCES |
| Date Received | 2004-08-31 |
| Decision Date | 2004-09-24 |
| PMA | P870024 |
| Supplement | S044 |
| Product Code | MUW |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| 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 |