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.
Alternate sheet casting process.
| Device | REZOOM MULTIFOCAL INTRAOCULAR LENS |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2016-06-01 |
| Decision Date | 2016-06-27 |
| PMA | P960028 |
| Supplement | S039 |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |