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 to modify the labeling to include the addition of 0. 25 diopter increments for the +17 to +27 power range for the crystalens accommodating intraocular lens, model at52ao.
| Device | CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS |
| Generic Name | Lens, Intraocular, Accommodative |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2011-07-14 |
| Decision Date | 2011-09-08 |
| PMA | P030002 |
| Supplement | S024 |
| Product Code | NAA |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |