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 with the supplier of the raw material processing for the soflens66 and soflens toric (alphafilcon a) soft contact lenses.
| Device | BAUSCH & LOMB SOFLENS 66 & SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2011-03-03 |
| Decision Date | 2011-03-28 |
| PMA | P960022 |
| 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 | 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 |