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.
Ethylene oxide and ethylene chlorohydrin residual testing for the silicone and pmma intraocular lenses be transferred to a new testing laboratory.
| Device | SofPort Posterior Chamber Intraocular Lenses |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | BAUSCH & LOMB |
| Date Received | 2019-01-04 |
| Decision Date | 2019-02-28 |
| PMA | P910061 |
| Supplement | S025 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAUSCH & LOMB 50 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910061 | Original Filing | |
| S027 | 2021-12-22 | 30-day Notice |
| S026 | 2020-12-11 | 30-day Notice |
| S025 | 2019-01-04 | 30-day Notice |
| S024 | ||
| S023 | 2016-05-31 | 30-day Notice |
| S022 | 2015-10-15 | 30-day Notice |
| S021 | ||
| S020 | 2013-07-31 | 30-day Notice |
| S019 | 2009-11-02 | 30-day Notice |
| S018 | 2009-06-09 | 30-day Notice |
| S017 | 2008-06-19 | 30-day Notice |
| S016 | 2008-04-03 | 30-day Notice |
| S015 | 2006-08-30 | Real-time Process |
| S014 | 2006-04-03 | Real-time Process |
| S013 | 2006-03-30 | Real-time Process |
| S012 | 2004-03-29 | Normal 180 Day Track No User Fee |
| S011 | 2004-03-18 | Real-time Process |
| S010 | 2003-06-23 | 30-day Notice |
| S009 | 2003-06-11 | Real-time Process |
| S008 | 1999-02-10 | Real-time Process |
| S007 | 1998-12-18 | Normal 180 Day Track |
| S006 | 1998-12-01 | Real-time Process |
| S005 | 1998-10-29 | 135 Review Track For 30-day Notice |
| S004 | 1998-09-18 | Real-time Process |
| S003 | 1998-08-07 | Normal 180 Day Track |
| S002 | ||
| S001 | 1997-06-10 | Normal 180 Day Track |