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 an alternate elastomeric tip cap material (fm27) and the addition of a threaded plastic rigid tip cap (prtc) outer shell.
| Device | OCUCOAT SYRINGE PRODUCT |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2010-11-18 |
| Decision Date | 2012-02-03 |
| PMA | P860047 |
| Supplement | S025 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |