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.
Changing the power measurement method for toric and multifocal lenses.
| Device | Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophillic) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch And Lomb, Inc. |
| Date Received | 2019-08-14 |
| Decision Date | 2019-09-12 |
| PMA | P170035 |
| Supplement | S006 |
| Product Code | LPM |
| 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 And Lomb, Inc. 1400 North Goodman Street rochester, NY 14609 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170035 | Original Filing | |
| S017 | 2022-05-04 | 30-day Notice |
| S016 | 2022-02-22 | 30-day Notice |
| S015 | 2021-12-15 | 30-day Notice |
| S014 | ||
| S013 | 2021-06-03 | Real-time Process |
| S012 | 2021-03-12 | 30-day Notice |
| S011 | 2020-10-30 | 30-day Notice |
| S010 | 2020-09-29 | 30-day Notice |
| S009 | 2020-09-02 | 30-day Notice |
| S008 | 2020-06-18 | 30-day Notice |
| S007 | 2019-11-20 | 30-day Notice |
| S006 | 2019-08-14 | 30-day Notice |
| S005 | ||
| S004 | 2019-06-14 | 30-day Notice |
| S003 | 2019-02-04 | Normal 180 Day Track |
| S002 | ||
| S001 |