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.
Removal of an in-process raw material quality control test affecting the sodium hyaluronate (nahy) raw material for the amvisc and amvisc plus ophthalmic viscosurgicaldevices (ovds) and change the release specification criteria for amvisc and amvisc plus ovds.
| Device | Amvisc and Amvisc Plus Ophthalmic Viscosurgical (OVD) |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2020-09-02 |
| Decision Date | 2020-10-01 |
| PMA | P810025 |
| Supplement | S040 |
| Product Code | LZP |
| 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 |
|---|---|---|
| P810025 | Original Filing | |
| S043 | 2021-08-03 | 30-day Notice |
| S042 | 2021-06-09 | 30-day Notice |
| S041 | 2021-03-16 | 30-day Notice |
| S040 | 2020-09-02 | 30-day Notice |
| S039 | ||
| S038 | 2016-11-23 | Normal 180 Day Track |
| S037 | 2016-08-23 | Normal 180 Day Track No User Fee |
| S036 | ||
| S035 | 2014-08-01 | 30-day Notice |
| S034 | 2013-07-15 | 30-day Notice |
| S033 | 2013-03-21 | 30-day Notice |
| S032 | 2012-06-28 | 30-day Notice |
| S031 | 2012-06-27 | Special (immediate Track) |
| S030 | 2010-11-03 | 30-day Notice |
| S029 | 2010-09-30 | Normal 180 Day Track No User Fee |
| S028 | 2010-06-21 | Normal 180 Day Track |
| S027 | 2009-05-27 | Normal 180 Day Track |
| S026 | 2006-07-27 | 30-day Notice |
| S025 | 2006-02-17 | 30-day Notice |
| S024 | 2004-06-24 | 30-day Notice |
| S023 | 2004-05-12 | 30-day Notice |
| S022 | 2003-04-29 | 135 Review Track For 30-day Notice |
| S021 | 2002-05-10 | Normal 180 Day Track |
| S020 | 2002-03-22 | Normal 180 Day Track |
| S019 | ||
| S018 | ||
| S017 | ||
| S016 | ||
| S015 | 1994-07-26 | Normal 180 Day Track |
| S014 | ||
| S013 | 1988-12-23 | Normal 180 Day Track |
| S012 | ||
| S011 | 1988-07-01 | Normal 180 Day Track |
| S010 | 1988-05-03 | Normal 180 Day Track |
| S009 | 1988-01-25 | Normal 180 Day Track |
| S008 | 1988-01-05 | Normal 180 Day Track |
| S007 | 1987-11-03 | Special (immediate Track) |
| S006 | 1987-08-10 | Normal 180 Day Track |
| S005 | 1985-11-13 | |
| S004 | 1985-03-18 | |
| S003 | 1984-12-17 | |
| S002 | 1984-02-10 | |
| S001 | 1984-02-10 |