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 | FLEXENS (HEFILCON A) SOFT CONTACT LENS |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | PARAGON VISION SCIENCES |
| Date Received | 1990-02-09 |
| Decision Date | 1990-07-12 |
| PMA | N17976 |
| Supplement | S010 |
| 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 | PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17976 | Original Filing | |
| S010 | 1990-02-09 | Normal 180 Day Track |
| S009 | ||
| S008 | 1989-06-16 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | 1987-10-02 | Normal 180 Day Track |
| S004 | 1987-09-24 | Normal 180 Day Track |
| S003 | 1984-04-27 | |
| S002 | 1982-06-03 | |
| S001 | 1980-05-19 |