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 a manufacturing site change and change in terminal sterilization method (i. E. , e-beam to vapor hydrogen peroxide) of the product.
| Device | AMVISC & AMVISC PLUS |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2009-05-27 |
| Decision Date | 2012-06-14 |
| PMA | P810025 |
| Supplement | S027 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |
|---|---|---|
| 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 |