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 | POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) |
| Generic Name | Intraocular Lens |
| Applicant | BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS024 Date Received06/11/2003 Decision Date08/13/2003 Withdrawal Date 11/26/2008 Product Code HQL Advisory Committee Ophthalmic Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2003-06-11 |
| Decision Date | 2003-08-13 |
| PMA | P850059 |
| Supplement | S024 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAUSCH & LOMB SURGICAL, INC. 1400 N. Goodman St. rochester, NY 14609 PMA NumberP850059 Supplement NumberS024 Date Received06/11/2003 Decision Date08/13/2003 Withdrawal Date 11/26/2008 Product Code HQL Advisory Committee Ophthalmic Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS. |
| 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 |