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.
Increase to the sterilization load size to utilize more of the chamber capacity.
| Device | SOFT-FORM 55EW; LL-55; SOFTCON EW2 |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Unilens Corp., USA |
| Date Received | 2016-02-04 |
| Decision Date | 2016-02-29 |
| PMA | P890040 |
| Supplement | S008 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Unilens Corp., USA 10431 72nd St. North largo, FL 33777 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890040 | Original Filing | |
| S008 | 2016-02-04 | 30-day Notice |
| S007 | 2013-07-08 | 30-day Notice |
| S006 | 2007-12-31 | 135 Review Track For 30-day Notice |
| S005 | 1998-11-04 | Normal 180 Day Track |
| S004 | 1991-11-25 | Normal 180 Day Track |
| S003 | 1991-02-11 | Normal 180 Day Track |
| S002 | 1990-10-02 | Normal 180 Day Track |
| S001 | 1989-10-10 | Normal 180 Day Track |