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 | IGEL 67 CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | CONTAMAC LTD. |
| Date Received | 1989-01-06 |
| Decision Date | 1989-05-09 |
| PMA | P860009 |
| Supplement | S002 |
| 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 | CONTAMAC LTD. orchard House bearwalden Business Park essex CB11--4JX |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860009 | Original Filing | |
| S002 | 1989-01-06 | Normal 180 Day Track |
| S001 | 1987-02-11 | Normal 180 Day Track |