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 physician¿s labeling to include the addition of 0. 25 diopter increments for the crystalens model hd500 and hd520 as follows: the addition of 0. 25 diopter increments for model hd500 lenses in the +18 to +22 dioptric power range and for model hd520 lenses in the +16. 25 to +16. 75 dioptric power range.
| Device | CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL) |
| Generic Name | Lens, Intraocular, Accommodative |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2009-05-01 |
| Decision Date | 2009-06-30 |
| PMA | P030002 |
| Supplement | S019 |
| Product Code | NAA |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |