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 | AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR |
| Classification Name | Lens, Contact (polymethylmethacrylate) |
| Generic Name | Lens, Contact (polymethylmethacrylate) |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1988-02-19 |
| Decision Date | 1988-03-17 |
| PMA | P830070 |
| Supplement | S010 |
| Product Code | HPX |
| 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 | CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830070 | Original Filing | |
| S033 | 1989-09-11 | Normal 180 Day Track |
| S032 | 1989-02-09 | Normal 180 Day Track |
| S031 | 1988-12-13 | Normal 180 Day Track |
| S030 | 1988-11-15 | 30-Day Supplement |
| S029 | 1988-11-08 | 30-Day Supplement |
| S028 | 1988-10-28 | 30-Day Supplement |
| S027 | 1988-09-12 | 30-Day Supplement |
| S026 | 1988-09-08 | 30-Day Supplement |
| S025 | 1988-09-06 | 30-Day Supplement |
| S024 | 1988-08-26 | Normal 180 Day Track |
| S023 | 1988-08-15 | 30-Day Supplement |
| S022 | 1988-08-11 | 30-Day Supplement |
| S021 | 1988-08-01 | 30-Day Supplement |
| S020 | 1988-07-22 | 30-Day Supplement |
| S019 | 1988-07-15 | 30-Day Supplement |
| S018 | 1988-07-08 | 30-Day Supplement |
| S017 | 1988-07-05 | 30-Day Supplement |
| S016 | 1988-06-17 | 30-Day Supplement |
| S015 | 1988-04-11 | 30-Day Supplement |
| S014 | 1988-04-05 | 30-Day Supplement |
| S013 | 1988-03-23 | Normal 180 Day Track |
| S012 | 1988-03-01 | Normal 180 Day Track |
| S011 | 1988-02-29 | Normal 180 Day Track |
| S010 | 1988-02-19 | Normal 180 Day Track |
| S009 | 1988-02-03 | Normal 180 Day Track |
| S008 | 1988-01-27 | Normal 180 Day Track |
| S007 | 1988-01-06 | 30-Day Supplement |
| S006 | 1987-11-09 | 30-Day Supplement |
| S005 | 1987-07-01 | 30-Day Supplement |
| S004 | 1986-08-01 | Panel Track |
| S003 | 1985-11-04 | |
| S002 | 1985-01-28 | |
| S001 | 1985-01-11 | Normal 180 Day Track |