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 | SILSOFT (ELASTOFILCON A) CONTACT LENSES |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc.14853 Deveau Placeminnetonka, MN 55345 PMA NumberP850068 Supplement NumberS014 Date Received02/01/2022 Decision Date03/18/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-02-01 |
| Decision Date | 2022-03-18 |
| PMA | P850068 |
| Supplement | S014 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 14853 Deveau Place minnetonka, MN 55345 PMA NumberP850068 Supplement NumberS014 Date Received02/01/2022 Decision Date03/18/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Implementing An Alternate Packaging Configuration And Revisions To The Cosmetic Inspection Criteria For The Silsoft (elastofilcon A) Contact Lenses |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850068 | Original Filing | |
| S014 | 2022-02-01 | Normal 180 Day Track |
| S013 | 2019-07-15 | Real-time Process |
| S012 | 2014-09-19 | 30-day Notice |
| S011 | 2014-04-15 | 30-day Notice |
| S010 | 2014-04-15 | 30-day Notice |
| S009 | 2011-09-14 | 30-day Notice |
| S008 | 2001-01-09 | Normal 180 Day Track |
| S007 | 1991-06-18 | Normal 180 Day Track |
| S006 | 1990-11-05 | Normal 180 Day Track |
| S005 | 1990-11-05 | Normal 180 Day Track |
| S004 | 1989-10-18 | Normal 180 Day Track |
| S003 | 1988-07-22 | Special (immediate Track) |
| S002 | 1987-06-19 | Normal 180 Day Track |
| S001 | 1987-02-02 | 30-Day Supplement |