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.
Add an alternate site for its working cell bank manufacturer, add an alternate vitamin supplier and change sourced chemicals to usp grade.
| Device | AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD) |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2013-03-21 |
| Decision Date | 2013-04-24 |
| PMA | P810025 |
| Supplement | S033 |
| 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 |