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.
Approval for the addition of the following private label trade names: equate monthly single vision (balafilcon a) contact lens, equate monthly multi-focal (balafilcon a) contact lens, equate monthly toric (balafilcon a) contact lenses, and c-vue addvantage multifocal (balafilcon a) visibility tinted contact lenses. The device, as modified, will be marketed under the trade name the equate monthly single vision (balafilcon a) contact lens and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended bythe eye care professional. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2. 00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +8. 00d to -20. 00d when prescribed for up to 30 days of extended wear and from +20. 00d to -20. 00d for daily wear or extended wear up to 7 days. For further information please refer to the approval order.
| Device | BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2014-04-14 |
| Decision Date | 2014-07-11 |
| PMA | P980006 |
| Supplement | S022 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |