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 for modifications to the directions for use to instruct the end-user to verify the connection of the cannula to the syringe luer.
| Device | AMVISC/AMVISC PLUS OVDS |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2012-06-27 |
| Decision Date | 2012-07-27 |
| PMA | P810025 |
| Supplement | S031 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| 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 |
|---|---|---|
| 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 |