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 to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1. 0 ug/lens. "
| Device | 5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 1995-11-03 |
| Decision Date | 1997-10-07 |
| PMA | P880081 |
| Supplement | S019 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880081 | Original Filing | |
| S047 | 2022-11-09 | 30-day Notice |
| S046 | 2020-12-10 | 30-day Notice |
| S045 | ||
| S044 | ||
| S043 | 2019-05-28 | Special (immediate Track) |
| S042 | 2019-03-08 | Special (immediate Track) |
| S041 | 2018-04-11 | 30-day Notice |
| S040 | 2016-06-02 | 30-day Notice |
| S039 | 2015-04-01 | 30-day Notice |
| S038 | 2012-12-31 | 30-day Notice |
| S037 | 2011-11-14 | 135 Review Track For 30-day Notice |
| S036 | 2008-01-28 | 30-day Notice |
| S035 | 2007-10-02 | 30-day Notice |
| S034 | 2007-09-24 | 30-day Notice |
| S033 | 2007-05-07 | 30-day Notice |
| S032 | 2006-05-30 | Real-time Process |
| S031 | 2005-06-28 | 30-day Notice |
| S030 | 2005-01-03 | Real-time Process |
| S029 | 2003-08-06 | Special (immediate Track) |
| S028 | ||
| S027 | 2001-11-19 | Normal 180 Day Track |
| S026 | 2000-06-23 | Normal 180 Day Track |
| S025 | ||
| S024 | 1999-01-07 | Normal 180 Day Track |
| S023 | 1997-06-30 | Real-time Process |
| S022 | 1996-09-27 | Normal 180 Day Track |
| S021 | ||
| S020 | 1995-11-13 | Normal 180 Day Track |
| S019 | 1995-11-03 | Normal 180 Day Track |
| S018 | 1995-04-04 | Normal 180 Day Track |
| S017 | 1993-08-03 | Normal 180 Day Track |
| S016 | ||
| S015 | ||
| S014 | 1992-07-21 | Normal 180 Day Track |
| S013 | 1992-06-30 | Normal 180 Day Track |
| S012 | 1992-03-17 | Normal 180 Day Track |
| S011 | 1992-02-04 | Normal 180 Day Track |
| S010 | ||
| S009 | 1991-01-25 | Normal 180 Day Track |
| S008 | ||
| S007 | 1990-08-02 | Normal 180 Day Track |
| S006 | 1989-12-27 | Normal 180 Day Track |
| S005 | 1990-02-28 | Normal 180 Day Track |
| S004 | 1990-02-07 | Normal 180 Day Track |
| S003 | 1989-12-15 | Normal 180 Day Track |
| S002 | 1989-12-13 | Normal 180 Day Track |
| S001 | 1989-08-25 | Normal 180 Day Track |