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 1) change of the tip cap of the 10 ml hypac scf syringe from containing dry natural rubber material to latex-free material and 2) revision of the labeling to remove the "dry natural rubber" statement.
| Device | ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S) |
| Generic Name | Fluid, Intraocular |
| Applicant | BAUSCH & LOMB |
| Date Received | 2005-09-06 |
| Decision Date | 2005-12-16 |
| PMA | P910071 |
| Supplement | S007 |
| Product Code | LWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |