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 | PMMA ANTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | Intraocular Lens |
| Applicant | BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS022 Date Received08/16/1999 Decision Date05/08/2001 Withdrawal Date 11/26/2008 Product Code HQL Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Express Gmp Supplement Expedited Review Granted? No |
| Date Received | 1999-08-16 |
| Decision Date | 2001-05-08 |
| PMA | P850059 |
| Supplement | S022 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAUSCH & LOMB SURGICAL, INC. 1400 N. Goodman St. rochester, NY 14609 PMA NumberP850059 Supplement NumberS022 Date Received08/16/1999 Decision Date05/08/2001 Withdrawal Date 11/26/2008 Product Code HQL Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Express Gmp Supplement Expedited Review Granted? No Combination ProductNo Approval Order Statement APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850059 | Original Filing | |
| S024 | 2003-06-11 | Real-time Process |
| S023 | 1999-09-21 | Normal 180 Day Track |
| S022 | 1999-08-16 | Normal 180 Day Track |
| S021 | 1999-02-17 | Normal 180 Day Track |
| S020 | 1999-02-10 | Real-time Process |
| S019 | 1998-12-23 | Real-time Process |
| S018 | 1998-10-29 | 135 Review Track For 30-day Notice |
| S017 | 1998-08-07 | Normal 180 Day Track |
| S016 | 1995-10-31 | Normal 180 Day Track |
| S015 | ||
| S014 | 1989-12-20 | Normal 180 Day Track |
| S013 | 1989-09-08 | Normal 180 Day Track |
| S012 | 1989-01-11 | Normal 180 Day Track |
| S011 | 1988-12-28 | Normal 180 Day Track |
| S010 | 1988-12-21 | Normal 180 Day Track |
| S009 | 1988-12-19 | Normal 180 Day Track |
| S008 | 1988-08-22 | Special (immediate Track) |
| S007 | 1988-05-17 | Normal 180 Day Track |
| S006 | 1988-01-07 | Special (immediate Track) |
| S005 | 1987-12-14 | Normal 180 Day Track |
| S004 | ||
| S003 | ||
| S002 | ||
| S001 | 1987-02-20 | Normal 180 Day Track |