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.
Software update for generating lathe cutting files for paragon crt®100 (paflufocon d) and paragon crt dual axis® (paflufocon d) rigid gas permeable contact lenses in clear and tints.
| Device | Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | PARAGON VISION SCIENCES |
| Date Received | 2020-03-26 |
| Decision Date | 2020-04-20 |
| PMA | P870024 |
| Supplement | S053 |
| Product Code | NUU |
| 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 |