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 sterilization site located at cosmed, inc. , plainfield, new jersey.
| Device | OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2004-03-29 |
| Decision Date | 2004-05-27 |
| PMA | P860047 |
| Supplement | S018 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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 |
|---|---|---|
| P860047 | Original Filing | |
| S034 | 2020-06-15 | 135 Review Track For 30-day Notice |
| S033 | 2016-11-23 | Normal 180 Day Track |
| S032 | 2016-08-23 | Normal 180 Day Track No User Fee |
| S031 | 2015-07-01 | Normal 180 Day Track |
| S030 | ||
| S029 | 2014-12-24 | Real-time Process |
| S028 | 2014-03-07 | 30-day Notice |
| S027 | 2012-12-31 | 30-day Notice |
| S026 | 2012-07-02 | 30-day Notice |
| S025 | 2010-11-18 | Normal 180 Day Track |
| S024 | 2010-07-21 | Normal 180 Day Track No User Fee |
| S023 | 2009-11-02 | 30-day Notice |
| S022 | 2008-06-19 | 30-day Notice |
| S021 | 2008-06-12 | Real-time Process |
| S020 | 2007-10-04 | Normal 180 Day Track |
| S019 | 2006-01-24 | Normal 180 Day Track No User Fee |
| S018 | 2004-03-29 | Normal 180 Day Track No User Fee |
| S017 | ||
| S016 | 2004-03-18 | Real-time Process |
| S015 | 2003-05-08 | 135 Review Track For 30-day Notice |
| S014 | 2003-05-08 | 30-day Notice |
| S013 | 2003-04-10 | 30-day Notice |
| S012 | 2003-03-20 | 30-day Notice |
| S011 | 1996-05-13 | Normal 180 Day Track |
| S010 | 1995-05-31 | Normal 180 Day Track |
| S009 | 1995-04-24 | Normal 180 Day Track |
| S008 | 1994-06-03 | Normal 180 Day Track |
| S007 | 1993-03-08 | Normal 180 Day Track |
| S006 | ||
| S005 | 1992-02-28 | Normal 180 Day Track |
| S004 | 1992-02-25 | Normal 180 Day Track |
| S003 | 1992-02-25 | Normal 180 Day Track |
| S002 | 1990-06-07 | Normal 180 Day Track |
| S001 | 1989-11-09 | Normal 180 Day Track |