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 to the tear strength specification for the purevision (balafilcon a) product family.
| Device | PureVision (balafilcon A) Visibility Tinted Contact Lens |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2017-12-26 |
| Decision Date | 2018-03-29 |
| PMA | P980006 |
| Supplement | S026 |
| 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 |
|---|---|---|
| P980006 | Original Filing | |
| S035 | 2022-08-12 | 30-day Notice |
| S034 | 2022-02-22 | 30-day Notice |
| S033 | 2021-12-15 | 30-day Notice |
| S032 | 2021-06-03 | Real-time Process |
| S031 | ||
| S030 | 2020-09-02 | 30-day Notice |
| S029 | 2019-07-15 | Real-time Process |
| S028 | ||
| S027 | 2018-03-12 | 30-day Notice |
| S026 | 2017-12-26 | 30-day Notice |
| S025 | 2015-11-20 | 30-day Notice |
| S024 | 2015-02-20 | 30-day Notice |
| S023 | 2014-09-15 | 30-day Notice |
| S022 | 2014-04-14 | Normal 180 Day Track No User Fee |
| S021 | 2013-06-24 | 30-day Notice |
| S020 | 2011-06-08 | 30-day Notice |
| S019 | 2011-05-19 | 30-day Notice |
| S018 | 2010-12-03 | Normal 180 Day Track No User Fee |
| S017 | 2010-12-01 | 30-day Notice |
| S016 | 2010-12-01 | 30-day Notice |
| S015 | 2010-07-22 | Normal 180 Day Track |
| S014 | 2008-11-12 | Real-time Process |
| S013 | 2008-09-24 | Real-time Process |
| S012 | 2008-04-02 | Real-time Process |
| S011 | 2007-08-20 | 30-day Notice |
| S010 | 2006-08-24 | 30-day Notice |
| S009 | ||
| S008 | 2005-04-25 | Real-time Process |
| S007 | 2005-03-03 | Normal 180 Day Track |
| S006 | 2005-02-03 | Real-time Process |
| S005 | 2004-01-06 | Normal 180 Day Track No User Fee |
| S004 | 2001-05-30 | Panel Track |
| S003 | 2001-01-09 | Normal 180 Day Track |
| S002 | 1999-09-01 | Normal 180 Day Track |
| S001 | 1999-06-29 | Normal 180 Day Track |