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.
Perform moist heat sterilization in house at eyeonics? Rancho cucamonga facility.
| Device | CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) |
| Generic Name | Lens, Intraocular, Accommodative |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2006-07-24 |
| Decision Date | 2007-05-24 |
| PMA | P030002 |
| Supplement | S008 |
| Product Code | NAA |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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 |