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.
| Device | Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch And Lomb, Inc.1400 North Goodman Streetrochester, NY 14609 PMA NumberP170035 Supplement NumberS016 Date Received02/22/2022 Decision Date03/21/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-03-21 |
| PMA | P170035 |
| Supplement | S016 |
| 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 PMA NumberP170035 Supplement NumberS016 Date Received02/22/2022 Decision Date03/21/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement change To The Distillation And Storage Bottle Stabilizer Used In The Manufacture Of The Ultra® (samfilcon A) And Pure Vision (balafilcon A)® Product Families |
| 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 |