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.
Acceptance of an alternate autoclave.
| Device | SILSOFT (CLASTOFILCON A) CONTACT L ENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2014-04-15 |
| Decision Date | 2014-05-14 |
| PMA | P850068 |
| Supplement | S010 |
| 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 | Bausch & Lomb, Inc. 14853 Deveau Place minnetonka, MN 55345 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850068 | Original Filing | |
| S014 | 2022-02-01 | Normal 180 Day Track |
| S013 | 2019-07-15 | Real-time Process |
| S012 | 2014-09-19 | 30-day Notice |
| S011 | 2014-04-15 | 30-day Notice |
| S010 | 2014-04-15 | 30-day Notice |
| S009 | 2011-09-14 | 30-day Notice |
| S008 | 2001-01-09 | Normal 180 Day Track |
| S007 | 1991-06-18 | Normal 180 Day Track |
| S006 | 1990-11-05 | Normal 180 Day Track |
| S005 | 1990-11-05 | Normal 180 Day Track |
| S004 | 1989-10-18 | Normal 180 Day Track |
| S003 | 1988-07-22 | Special (immediate Track) |
| S002 | 1987-06-19 | Normal 180 Day Track |
| S001 | 1987-02-02 | 30-Day Supplement |