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 | Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc.1400 North Goodman St.rochester, NY 14609-3547 PMA NumberP980006 Supplement NumberS035 Date Received08/12/2022 Decision Date09/29/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-12 |
| Decision Date | 2022-09-29 |
| PMA | P980006 |
| Supplement | S035 |
| 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 & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547 PMA NumberP980006 Supplement NumberS035 Date Received08/12/2022 Decision Date09/29/2022 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 an Alternate Diluent Used In The Manufacture Of The PureVision® (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980006 | Original Filing | |
| S035 | 2022-08-12 | 30-day Notice |
| S034 | 2022-02-22 | 30-day Notice |
| S033 | 2021-12-15 | 30-day Notice |
| S032 | 2021-06-03 | Real-time Process |
| S031 | ||
| S030 | 2020-09-02 | 30-day Notice |
| S029 | 2019-07-15 | Real-time Process |
| S028 | ||
| S027 | 2018-03-12 | 30-day Notice |
| S026 | 2017-12-26 | 30-day Notice |
| S025 | 2015-11-20 | 30-day Notice |
| S024 | 2015-02-20 | 30-day Notice |
| S023 | 2014-09-15 | 30-day Notice |
| S022 | 2014-04-14 | Normal 180 Day Track No User Fee |
| S021 | 2013-06-24 | 30-day Notice |
| S020 | 2011-06-08 | 30-day Notice |
| S019 | 2011-05-19 | 30-day Notice |
| S018 | 2010-12-03 | Normal 180 Day Track No User Fee |
| S017 | 2010-12-01 | 30-day Notice |
| S016 | 2010-12-01 | 30-day Notice |
| S015 | 2010-07-22 | Normal 180 Day Track |
| S014 | 2008-11-12 | Real-time Process |
| S013 | 2008-09-24 | Real-time Process |
| S012 | 2008-04-02 | Real-time Process |
| S011 | 2007-08-20 | 30-day Notice |
| S010 | 2006-08-24 | 30-day Notice |
| S009 | ||
| S008 | 2005-04-25 | Real-time Process |
| S007 | 2005-03-03 | Normal 180 Day Track |
| S006 | 2005-02-03 | Real-time Process |
| S005 | 2004-01-06 | Normal 180 Day Track No User Fee |
| S004 | 2001-05-30 | Panel Track |
| S003 | 2001-01-09 | Normal 180 Day Track |
| S002 | 1999-09-01 | Normal 180 Day Track |
| S001 | 1999-06-29 | Normal 180 Day Track |