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.
| Device | OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | PARAGON VISION SCIENCES |
| Date Received | 1993-03-24 |
| Decision Date | 1993-04-14 |
| PMA | P820056 |
| Supplement | S054 |
| Product Code | HQD |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location 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 |
|---|---|---|
| P820056 | Original Filing | |
| S056 | 1993-11-12 | Normal 180 Day Track |
| S055 | 1993-11-12 | Normal 180 Day Track |
| S054 | 1993-03-24 | Normal 180 Day Track |
| S053 | 1992-10-20 | Normal 180 Day Track |
| S052 | 1992-02-20 | Normal 180 Day Track |
| S051 | 1992-02-11 | Normal 180 Day Track |
| S050 | 1992-01-27 | Normal 180 Day Track |
| S049 | 1991-07-31 | Normal 180 Day Track |
| S048 | 1991-06-14 | Normal 180 Day Track |
| S047 | 1990-03-14 | Normal 180 Day Track |
| S046 | 1989-10-11 | Normal 180 Day Track |
| S045 | 1989-08-07 | Normal 180 Day Track |
| S044 | 1989-05-23 | Normal 180 Day Track |
| S043 | 1989-04-20 | Normal 180 Day Track |
| S042 | 1988-06-21 | 30-Day Supplement |
| S041 | 1988-06-17 | 30-Day Supplement |
| S040 | ||
| S039 | ||
| S038 | ||
| S037 | 1988-04-06 | Normal 180 Day Track |
| S036 | 1988-04-01 | Normal 180 Day Track |
| S035 | 1988-01-15 | 30-Day Supplement |
| S034 | ||
| S033 | ||
| S032 | 1987-12-29 | 30-Day Supplement |
| S031 | 1987-11-19 | 30-Day Supplement |
| S030 | 1987-08-31 | 30-Day Supplement |
| S029 | 1987-06-09 | 30-Day Supplement |
| S028 | ||
| S027 | 1987-04-06 | 30-Day Supplement |
| S026 | 1987-01-05 | 30-Day Supplement |
| S025 | 1987-02-02 | 30-Day Supplement |
| S024 | 1987-01-29 | Normal 180 Day Track |
| S023 | 1986-12-29 | Normal 180 Day Track |
| S022 | 1986-11-17 | 30-Day Supplement |
| S021 | 1986-09-23 | Normal 180 Day Track |
| S020 | 1986-09-05 | 30-Day Supplement |
| S019 | ||
| S018 | 1986-05-06 | |
| S017 | 1986-04-29 | |
| S016 | 1986-04-16 | |
| S015 | ||
| S014 | 1986-04-01 | |
| S013 | 1986-02-11 | Normal 180 Day Track |
| S012 | 1985-12-27 | Normal 180 Day Track |
| S011 | 1985-08-19 | |
| S010 | 1985-08-19 | |
| S009 | 1985-05-02 | |
| S008 | ||
| S007 | 1984-09-17 | |
| S006 | 1984-05-03 | |
| S005 | 1984-01-20 | |
| S004 | ||
| S003 | 1983-11-03 | |
| S002 | 1983-08-08 | |
| S001 | 1983-05-11 |