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 | PARAPERM O2 CONTACT LENS |
| Classification Name | Lens, Contact (polymethylmethacrylate) |
| Generic Name | Lens, Contact (polymethylmethacrylate) |
| Applicant | PARAGON OPTICAL CO. |
| Date Received | 1987-10-08 |
| Decision Date | 1988-04-06 |
| PMA | P820063 |
| Supplement | S025 |
| Product Code | HPX |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PARAGON OPTICAL CO. 947 East Impala Ave. mesa, AZ 85204 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820063 | Original Filing | |
| S055 | 1993-11-12 | Normal 180 Day Track |
| S054 | 1993-11-12 | Normal 180 Day Track |
| S053 | 1993-03-24 | Normal 180 Day Track |
| S052 | 1992-02-20 | Normal 180 Day Track |
| S051 | 1992-02-11 | Normal 180 Day Track |
| S050 | 1992-01-27 | 30-Day Supplement |
| S049 | 1991-07-31 | Normal 180 Day Track |
| S048 | 1990-12-06 | 30-Day Supplement |
| S047 | 1990-10-05 | Normal 180 Day Track |
| S046 | 1990-06-20 | 30-Day Supplement |
| S045 | 1990-04-18 | 30-Day Supplement |
| S044 | 1990-03-14 | 30-Day Supplement |
| S043 | 1990-02-12 | Normal 180 Day Track |
| S042 | 1989-10-11 | Normal 180 Day Track |
| S041 | 1989-08-02 | Normal 180 Day Track |
| S040 | 1989-05-15 | Normal 180 Day Track |
| S039 | 1989-04-12 | Normal 180 Day Track |
| S038 | 1989-01-18 | Normal 180 Day Track |
| S037 | 1988-11-09 | 30-Day Supplement |
| S036 | 1988-06-10 | 30-Day Supplement |
| S035 | 1988-05-09 | 30-Day Supplement |
| S034 | ||
| S033 | ||
| S032 | 1988-04-04 | 30-Day Supplement |
| S031 | ||
| S030 | 1988-03-07 | Normal 180 Day Track |
| S029 | ||
| S028 | 1988-01-11 | 30-Day Supplement |
| S027 | ||
| S026 | ||
| S025 | 1987-10-08 | Normal 180 Day Track |
| S024 | 1987-10-08 | Normal 180 Day Track |
| S023 | ||
| S022 | 1987-09-17 | Normal 180 Day Track |
| S021 | ||
| S020 | 1987-08-25 | 30-Day Supplement |
| S019 | 1987-06-04 | 30-Day Supplement |
| S018 | 1987-05-22 | 30-Day Supplement |
| S017 | 1987-04-09 | 30-Day Supplement |
| S016 | 1986-06-09 | Normal 180 Day Track |
| S015 | 1986-06-09 | Normal 180 Day Track |
| S014 | 1985-04-17 | |
| S013 | 1985-02-08 | |
| S012 | 1985-01-31 | |
| S011 | 1984-12-12 | |
| S010 | 1984-07-20 | |
| S009 | 1984-07-18 | |
| S008 | 1984-06-01 | |
| S007 | 1984-06-04 | Normal 180 Day Track |
| S006 | 1984-03-30 | |
| S005 | 1984-03-13 | |
| S004 | 1984-03-12 | |
| S003 | ||
| S002 | 1983-11-04 | |
| S001 | 1983-11-29 |
| Device ID | PMA | Supp |
|---|---|---|
| B22202 | P820063 | 001 |