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 ixide residual from "not to exceed 25 ppm" to "not to exceed 1. 0 ug/lens. "
| Device | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 1997-09-19 |
| Decision Date | 1997-10-07 |
| PMA | P960028 |
| Supplement | S001 |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| 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 |
|---|---|---|
| P960028 | Original Filing | |
| S040 | 2017-09-28 | 30-day Notice |
| S039 | 2016-06-01 | 30-day Notice |
| S038 | 2015-12-18 | 30-day Notice |
| S037 | 2013-05-24 | 30-day Notice |
| S036 | 2012-04-23 | 30-day Notice |
| S035 | 2011-11-14 | 135 Review Track For 30-day Notice |
| S034 | ||
| S033 | ||
| S032 | 2009-07-30 | 135 Review Track For 30-day Notice |
| S031 | 2008-11-24 | 30-day Notice |
| S030 | 2008-08-29 | 30-day Notice |
| S029 | 2008-01-28 | 30-day Notice |
| S028 | 2008-01-28 | 30-day Notice |
| S027 | 2007-12-17 | 135 Review Track For 30-day Notice |
| S026 | 2007-12-14 | 30-day Notice |
| S025 | 2007-10-02 | 30-day Notice |
| S024 | 2007-09-24 | 30-day Notice |
| S023 | 2007-08-09 | 30-day Notice |
| S022 | 2007-06-13 | 30-day Notice |
| S021 | 2007-05-07 | 30-day Notice |
| S020 | 2007-03-28 | 30-day Notice |
| S019 | 2007-03-27 | 30-day Notice |
| S018 | 2007-02-20 | 30-day Notice |
| S017 | 2007-02-20 | 30-day Notice |
| S016 | 2006-10-10 | 30-day Notice |
| S015 | 2006-09-19 | 30-day Notice |
| S014 | 2005-06-28 | 30-day Notice |
| S013 | 2005-06-28 | Normal 180 Day Track |
| S012 | ||
| S011 | 2004-10-04 | Normal 180 Day Track |
| S010 | 2003-08-06 | Special (immediate Track) |
| S009 | 2003-06-02 | Normal 180 Day Track |
| S008 | ||
| S007 | 2001-11-19 | Normal 180 Day Track |
| S006 | 2000-10-02 | Normal 180 Day Track |
| S005 | 1999-10-21 | Real-time Process |
| S004 | 1998-10-23 | Normal 180 Day Track |
| S003 | 1998-08-28 | Normal 180 Day Track |
| S002 | 1997-10-24 | Normal 180 Day Track |
| S001 | 1997-09-19 |