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.
Change from the use of animal to vegetable-based additives in the production of resin used to make casting molds for production of soflens® (polymacon) and soflens® toric (alphafilcon a) contact lenses at the rochester, ny and waterford, ireland manufacturing sites.
| Device | SofLens Toric (alphafilcon A) Contact Lenses |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2020-03-20 |
| Decision Date | 2020-04-13 |
| PMA | P960022 |
| Supplement | S012 |
| 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. 1400 North Goodman St. rochester, NY 14609-3547 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960022 | Original Filing | |
| S012 | 2020-03-20 | 30-day Notice |
| S011 | 2015-09-29 | 30-day Notice |
| S010 | 2013-10-17 | 30-day Notice |
| S009 | 2011-10-19 | 135 Review Track For 30-day Notice |
| S008 | 2011-03-03 | 30-day Notice |
| S007 | 2010-11-15 | Normal 180 Day Track No User Fee |
| S006 | 2010-05-17 | 30-day Notice |
| S005 | 2008-09-24 | Real-time Process |
| S004 | 2004-02-06 | 30-day Notice |
| S003 | 2003-03-03 | Real-time Process |
| S002 | 2001-01-09 | Normal 180 Day Track |
| S001 | 1997-08-07 | Normal 180 Day Track |