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 for an alternate biological indicator, the 3m attest rapid readout biological indicator, to monitor the sterilization processes and to use only the fluorescent enzyme 3 hour readout system for routine disposition of the product. The fluorescent readout system by itself will not be used to validate the sterilization processes.
| Device | BAUSCH AND LOMB ELASTOFILCON A HYDROPHILIC CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2001-01-09 |
| Decision Date | 2002-06-28 |
| PMA | P850068 |
| Supplement | S008 |
| 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 |
| 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 |