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 for modification of the indication statement with standardized language for the models of the array family of multifocal intraocular lenses (models sa40n, sa40n2, sa40e, aa40e, aa50 and nxg1). The devices, as modified, will be marketed under the trade name array and are indicated for: the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed and who desire near, intermediate, and distance vision without reading add and increased spectacle, independence.
| Device | ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2005-06-28 |
| Decision Date | 2005-12-21 |
| PMA | P960028 |
| Supplement | S013 |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |