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 | STERILIZED FINISHED OCUFILCON B LENSES |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | OCU-EASE OPTICAL PRODUCTS, INC. |
| Date Received | 1989-11-02 |
| Decision Date | 1990-06-28 |
| PMA | P820051 |
| 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 | OCU-EASE OPTICAL PRODUCTS, INC. 629 Tennent Ave. pinole, CA 94564 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820051 | Original Filing | |
| S015 | 1992-02-18 | Normal 180 Day Track |
| S014 | 1991-03-25 | Normal 180 Day Track |
| S013 | ||
| S012 | 1989-12-15 | Normal 180 Day Track |
| S011 | ||
| S010 | 1989-11-02 | Normal 180 Day Track |
| S009 | 1989-09-22 | Normal 180 Day Track |
| S008 | 1988-06-07 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | ||
| S004 | ||
| S003 | 1986-06-03 | Normal 180 Day Track |
| S002 | 1985-08-05 | |
| S001 |