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 following changes for adato sil-ol 5000 silicone oil: 1) addition of a new primary container closure system (glass syringe); 2) pharm pur gmbh, augsburg, germany, as the site for filling, sterilization, labeling and packaging for adato sil-ol 5000 silicone oil packaged in a syringe; 3) parametric release of the adato sil-ol 5000 silicone oil syringe packaged product in lieu of end product sterility testing; and 4) double pouch packaging for adato sil-ol 5000 silicone oil syringe.
| Device | ADATO SIL-OL 5000 SILICONE OIL SYRINGE |
| Generic Name | Fluid, Intraocular |
| Applicant | BAUSCH & LOMB |
| Date Received | 2002-01-29 |
| Decision Date | 2002-12-23 |
| PMA | P910071 |
| Supplement | S006 |
| Product Code | LWL |
| 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 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 |