This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | ADATOMED SILICONE OIL OP5000 |
| Generic Name | Fluid, Intraocular |
| Applicant | BAUSCH & LOMB |
| Date Received | 1991-12-16 |
| Decision Date | 1994-11-04 |
| Notice Date | 1995-07-20 |
| PMA | P910071 |
| Supplement | S |
| Product Code | LWL |
| Docket Number | 95M-0180 |
| Advisory Committee | Ophthalmic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | BAUSCH & LOMB 50 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910071 | Original Filing | |
| S018 | 2021-11-03 | 30-day Notice |
| S017 | ||
| S016 | 2015-11-19 | Real-time Process |
| S015 | 2015-08-07 | 30-day Notice |
| S014 | 2012-08-10 | Special (immediate Track) |
| S013 | 2010-12-29 | Real-time Process |
| S012 | 2008-07-07 | Normal 180 Day Track No User Fee |
| S011 | 2007-12-17 | Normal 180 Day Track No User Fee |
| S010 | 2007-07-11 | Real-time Process |
| S009 | 2006-09-19 | 135 Review Track For 30-day Notice |
| S008 | 2006-01-13 | 30-day Notice |
| S007 | 2005-09-06 | Real-time Process |
| S006 | 2002-01-29 | Normal 180 Day Track |
| S005 | 2000-06-05 | Normal 180 Day Track |
| S004 | 1997-07-08 | Normal 180 Day Track |
| S003 | ||
| S002 | 1994-12-28 | Normal 180 Day Track |
| S001 | 1994-11-18 | Normal 180 Day Track |