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 to remove the sagittal depth measurement acceptance criteria from the finished product specifications for ultra (samfilcon a) contact lens.
| Device | Ultra (samfilcon A) Contact Lens |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch And Lomb, Inc. |
| Date Received | 2021-06-03 |
| Decision Date | 2021-08-27 |
| PMA | P170035 |
| Supplement | S013 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |