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 | KONTUR SOFT (METHAFILCON A) LENS |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | KONTUR KONTACT LENS CO., INC. |
| Date Received | 1989-07-24 |
| Decision Date | 1989-12-11 |
| PMA | P850078 |
| Supplement | S012 |
| Product Code | LPL |
| 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 | KONTUR KONTACT LENS CO., INC. 642 Alfred Nobel Dr. hercules, CA 94547 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850078 | Original Filing | |
| S013 | 1989-07-18 | Normal 180 Day Track |
| S012 | 1989-07-24 | Normal 180 Day Track |
| S011 | ||
| S010 | 1988-08-23 | Normal 180 Day Track |
| S009 | ||
| S008 | 1987-04-10 | 30-Day Supplement |
| S007 | 1987-04-15 | Normal 180 Day Track |
| S006 | 1987-03-05 | Normal 180 Day Track |
| S005 | ||
| S004 | 1987-03-05 | Normal 180 Day Track |
| S003 | 1987-03-05 | Normal 180 Day Track |
| S002 | 1986-08-04 | Normal 180 Day Track |
| S001 | 1985-10-02 |