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 | DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1989-02-09 |
| Decision Date | 1989-08-28 |
| PMA | P850072 |
| Supplement | S003 |
| Product Code | LPM |
| 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 |
|---|---|---|
| P850072 | Original Filing | |
| S007 | 1989-09-25 | Normal 180 Day Track |
| S006 | 1989-09-18 | Normal 180 Day Track |
| S005 | 1989-09-11 | Normal 180 Day Track |
| S004 | 1989-07-20 | Normal 180 Day Track |
| S003 | 1989-02-09 | Normal 180 Day Track |
| S002 | 1987-11-12 | Panel Track |
| S001 | 1986-08-05 | Normal 180 Day Track |