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 for the following devices and indications: the paragon crt (paflufocon b) and paragon crt 100 (paglufocon d) rigid gas permeable contact lenses for corneal refractive therapy are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in a contact lenses corneal refractive therapy fitting program for the temporary reduction of myopia up to 6. 00 diopters in eyes with astigmatism up to 1. 75 diopters. The lenses may be disinfected using only a chemical disinfection system. The paragon quadra rg (paflufocon b) and paragon quadra rg 100 (paflufocon d) rigid gas permeable contact lenses for corneal refractive therapy are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in a contact lens corneal refractive therapy fitting program for the temporary reduction of myopia up to 3. 00 diopters in eyes with astigmatism up to 1. 50 diopters. The lenses may be disinfected using only a chemical disinfection system. Note: to maintain the contact lens corneal refractive therapy effect of myopia reduction overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e. G. , night driving), visual fluctuations and changes in intended correction.
| Device | PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100.. |
| Classification Name | Lens, Contact, Orthokeratology, Overnight |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | PARAGON VISION SCIENCES |
| Date Received | 2001-10-02 |
| Decision Date | 2002-06-13 |
| Notice Date | 2002-07-02 |
| PMA | P870024 |
| Supplement | S043 |
| Product Code | NUU |
| Docket Number | 02M-0295 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |