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.
Requested that a phase iv trial of adatosil 5000(tm) no longer be required as a condition of approval for this pma, and that the current labeling be revised to state more specificaly the role of the physician in determining the use and removal of adatosil 5000(tm) silicone oil.
| Device | ADATO SIL 5000 |
| Generic Name | Fluid, Intraocular |
| Applicant | BAUSCH & LOMB |
| Date Received | 1997-07-08 |
| Decision Date | 1997-12-24 |
| PMA | P910071 |
| Supplement | S004 |
| Product Code | LWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| Expedited Review | No |
| 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 |