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 the labeling changes to your directions for use (dfu). The dfu was revised to include safety information regarding the use of co2 lasers in instances where silicone oil may have migrated out of the eye and formed lesions in the conjuctiva or eyelid.
| Device | ADATO SIL-O1 5000 SILICONE OIL |
| Generic Name | Fluid, Intraocular |
| Applicant | BAUSCH & LOMB |
| Date Received | 2012-08-10 |
| Decision Date | 2012-08-31 |
| PMA | P910071 |
| Supplement | S014 |
| Product Code | LWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |