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 E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN |
| Classification Name | Lens, Contact (other Material) - Daily |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | PARAGON OPTICAL CO. |
| Date Received | 1989-05-15 |
| Decision Date | 1989-12-27 |
| PMA | P850038 |
| Supplement | S007 |
| Product Code | HQD |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PARAGON OPTICAL CO. 947 East Impala Ave. mesa, AZ 85204 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850038 | Original Filing | |
| S023 | 1993-11-12 | Normal 180 Day Track |
| S022 | 1993-11-12 | Normal 180 Day Track |
| S021 | 1993-03-24 | Normal 180 Day Track |
| S020 | 1992-10-20 | Normal 180 Day Track |
| S019 | 1992-02-20 | Normal 180 Day Track |
| S018 | 1992-02-11 | Normal 180 Day Track |
| S017 | 1992-01-27 | 30-Day Supplement |
| S016 | 1991-07-31 | Normal 180 Day Track |
| S015 | 1990-12-06 | 30-Day Supplement |
| S014 | 1990-10-05 | Normal 180 Day Track |
| S013 | 1990-06-20 | 30-Day Supplement |
| S012 | 1990-04-18 | Normal 180 Day Track |
| S011 | 1990-03-14 | 30-Day Supplement |
| S010 | 1990-02-12 | Normal 180 Day Track |
| S009 | 1989-10-11 | Normal 180 Day Track |
| S008 | 1989-08-02 | Normal 180 Day Track |
| S007 | 1989-05-15 | Normal 180 Day Track |
| S006 | 1989-04-12 | Normal 180 Day Track |
| S005 | 1989-01-18 | Normal 180 Day Track |
| S004 | ||
| S003 | 1987-10-08 | Normal 180 Day Track |
| S002 | ||
| S001 | 1987-09-17 | Normal 180 Day Track |