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.
Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.
| Device | Crystalens Accommodating Posterior Chamber & Trulign Toric Intraocular Lenses (IOL) |
| Generic Name | Lens, Intraocular, Accommodative |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2021-12-22 |
| Decision Date | 2022-01-19 |
| PMA | P030002 |
| Supplement | S040 |
| Product Code | NAA |
| 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. 50 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030002 | Original Filing | |
| S040 | 2021-12-22 | 30-day Notice |
| S039 | ||
| S038 | 2016-02-01 | Normal 180 Day Track |
| S037 | 2015-12-18 | Normal 180 Day Track No User Fee |
| S036 | 2015-12-15 | Real-time Process |
| S035 | 2015-07-02 | Normal 180 Day Track No User Fee |
| S034 | 2015-04-01 | Normal 180 Day Track No User Fee |
| S033 | 2015-01-26 | Real-time Process |
| S032 | 2014-11-13 | 30-day Notice |
| S031 | 2014-04-14 | 30-day Notice |
| S030 | 2014-02-24 | 30-day Notice |
| S029 | 2014-01-16 | 30-day Notice |
| S028 | 2013-06-18 | Normal 180 Day Track No User Fee |
| S027 | 2012-03-27 | Panel Track |
| S026 | ||
| S025 | 2011-08-18 | 30-day Notice |
| S024 | 2011-07-14 | Real-time Process |
| S023 | 2011-02-24 | 30-day Notice |
| S022 | 2010-03-08 | Real-time Process |
| S021 | 2009-08-26 | Real-time Process |
| S020 | 2009-06-02 | Normal 180 Day Track |
| S019 | 2009-05-01 | Real-time Process |
| S018 | 2009-01-27 | 30-day Notice |
| S017 | 2008-08-07 | 30-day Notice |
| S016 | 2008-06-17 | 30-day Notice |
| S015 | 2008-05-15 | Normal 180 Day Track No User Fee |
| S014 | 2007-12-17 | Normal 180 Day Track |
| S013 | 2007-11-05 | Real-time Process |
| S012 | 2007-08-28 | 30-day Notice |
| S011 | 2007-04-25 | 30-day Notice |
| S010 | 2007-04-06 | Real-time Process |
| S009 | 2007-03-05 | Real-time Process |
| S008 | 2006-07-24 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | 2005-10-20 | Normal 180 Day Track No User Fee |
| S005 | 2005-08-23 | Special (immediate Track) |
| S004 | 2005-07-05 | Real-time Process |
| S003 | 2005-05-04 | Normal 180 Day Track No User Fee |
| S002 | 2004-08-30 | Special (immediate Track) |
| S001 | 2004-06-28 | Real-time Process |