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 | KELMAN(TM) OMNIFIT II MODEL 2100 |
| Generic Name | Intraocular Lens |
| Applicant | BAUSCH & LOMB SURGICAL, INC.1400 N. Goodman St.rochester, NY 14609 PMA NumberP850059 Supplement NumberS008 Date Received08/22/1988 Decision Date10/03/1988 Withdrawal Date 11/26/2008 Product Code HQL Advisory Committee Ophthalmic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 1988-08-22 |
| Decision Date | 1988-10-03 |
| PMA | P850059 |
| Supplement | S008 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| 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 NumberS008 Date Received08/22/1988 Decision Date10/03/1988 Withdrawal Date 11/26/2008 Product Code HQL Advisory Committee Ophthalmic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo |
| 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 |