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 "indications" statements for all legally marketed iols under the above referenced pmas to reflect adults as opposed to adults older than 60 years of age.
| Device | UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2005-01-03 |
| Decision Date | 2005-02-04 |
| PMA | P880081 |
| Supplement | S030 |
| 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 | 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 |