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 | SIMULVUE (HEFILCON A) BIFOCAL CONTACT LENS |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | Unilens Corp., USA |
| Date Received | 1991-12-13 |
| Decision Date | 1993-11-17 |
| PMA | P850002 |
| Supplement | S009 |
| 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 | Unilens Corp., USA 10431 72nd St. North p.o. Box 2530 largo, FL 34647 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850002 | Original Filing | |
| S009 | 1991-12-13 | Normal 180 Day Track |
| S008 | 1991-12-13 | Normal 180 Day Track |
| S007 | 1991-02-22 | Normal 180 Day Track |
| S006 | 1991-02-01 | Normal 180 Day Track |
| S005 | 1989-02-17 | Normal 180 Day Track |
| S004 | ||
| S003 | 1988-10-05 | Normal 180 Day Track |
| S002 | 1988-01-20 | Normal 180 Day Track |
| S001 | 1985-08-13 |