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 | ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | HANITA CONTACT LENS LABORATORY |
| Date Received | 1989-09-12 |
| Decision Date | 1990-03-28 |
| PMA | P870019 |
| Supplement | S003 |
| Product Code | LPL |
| 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 | HANITA CONTACT LENS LABORATORY 333 East 57th St. new York, NY 10022 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870019 | Original Filing | |
| S003 | 1989-09-12 | Normal 180 Day Track |
| S002 | 1989-07-14 | Normal 180 Day Track |
| S001 | 1989-04-28 | Normal 180 Day Track |