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 | HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | RAND SCIENTIFIC CORP. |
| Date Received | 1991-02-13 |
| Decision Date | 1991-04-05 |
| PMA | P890044 |
| Supplement | S011 |
| 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 | RAND SCIENTIFIC CORP. 4135 Northgate Blvd., Suite 9 sacramento, CA 95834 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890044 | Original Filing | |
| S027 | 1993-12-21 | Normal 180 Day Track |
| S026 | 1993-04-29 | Normal 180 Day Track |
| S025 | 1993-01-21 | Normal 180 Day Track |
| S024 | 1992-12-15 | Normal 180 Day Track |
| S023 | 1992-08-07 | Normal 180 Day Track |
| S022 | 1992-07-10 | Normal 180 Day Track |
| S021 | 1992-05-06 | Normal 180 Day Track |
| S020 | 1992-03-24 | Normal 180 Day Track |
| S019 | 1992-01-15 | Normal 180 Day Track |
| S018 | 1991-11-21 | Normal 180 Day Track |
| S017 | 1991-09-27 | Normal 180 Day Track |
| S016 | 1991-08-22 | Normal 180 Day Track |
| S015 | 1991-06-20 | Normal 180 Day Track |
| S014 | 1991-05-24 | Normal 180 Day Track |
| S013 | 1991-04-30 | Normal 180 Day Track |
| S012 | 1991-02-15 | Normal 180 Day Track |
| S011 | 1991-02-13 | Normal 180 Day Track |
| S010 | 1990-12-05 | 30-Day Supplement |
| S009 | 1990-09-20 | 30-Day Supplement |
| S008 | 1990-08-09 | 30-Day Supplement |
| S007 | 1990-07-16 | Normal 180 Day Track |
| S006 | 1990-06-26 | Normal 180 Day Track |
| S005 | 1990-06-14 | Special (immediate Track) |
| S004 | 1990-06-04 | Normal 180 Day Track |
| S003 | 1990-05-16 | Normal 180 Day Track |
| S002 | 1990-03-29 | Normal 180 Day Track |
| S001 | 1990-03-29 | Normal 180 Day Track |