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.
Transfer of bioburden testing of the akreos adapt ao holder folder, m160 holder, and parker gasket from a contract vendor to bausch & lomb.
| Device | AKREOS ADAPT AO HOLDER FOLDER/M160 HOLDER/PARKER GASKET |
| Generic Name | Intraocular Lens |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2011-03-18 |
| Decision Date | 2011-10-07 |
| PMA | P060022 |
| Supplement | S009 |
| Product Code | HQL |
| 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 |
|---|---|---|
| P060022 | Original Filing | |
| S030 | 2022-08-16 | 30-day Notice |
| S029 | 2021-12-22 | 30-day Notice |
| S028 | 2020-12-04 | 30-day Notice |
| S027 | ||
| S026 | ||
| S025 | 2019-12-23 | 30-day Notice |
| S024 | 2018-07-10 | 30-day Notice |
| S023 | 2016-06-03 | 30-day Notice |
| S022 | 2015-09-11 | 135 Review Track For 30-day Notice |
| S021 | 2015-02-18 | 30-day Notice |
| S020 | 2014-12-08 | Real-time Process |
| S019 | 2014-05-15 | 30-day Notice |
| S018 | ||
| S017 | 2013-06-10 | 30-day Notice |
| S016 | 2013-04-15 | Real-time Process |
| S015 | 2013-02-22 | 30-day Notice |
| S014 | 2012-08-20 | 30-day Notice |
| S013 | 2012-03-20 | Real-time Process |
| S012 | 2011-06-21 | Normal 180 Day Track |
| S011 | 2011-05-09 | 30-day Notice |
| S010 | 2011-02-16 | Normal 180 Day Track No User Fee |
| S009 | 2011-03-18 | 30-day Notice |
| S008 | 2011-03-18 | 135 Review Track For 30-day Notice |
| S007 | 2010-04-30 | 30-day Notice |
| S006 | 2010-01-29 | Real-time Process |
| S005 | 2009-08-25 | 30-day Notice |
| S004 | 2009-03-06 | 30-day Notice |
| S003 | ||
| S002 | 2008-10-24 | Real-time Process |
| S001 | 2008-10-20 | 30-day Notice |