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 changes to the physician and patient labeling.
| Device | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 1998-08-28 |
| Decision Date | 1999-02-24 |
| PMA | P960028 |
| Supplement | S003 |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |
|---|---|---|
| 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 |