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 expand the diopter range of the array(r) iol from 16-24d to 6-30d in half diopter increments.
| Device | AMO ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR (IOL) |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 1998-10-23 |
| Decision Date | 1999-06-08 |
| PMA | P960028 |
| Supplement | S004 |
| Product Code | MFK |
| 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 |
|---|---|---|
| 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 |