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 an alternate manufacturing site located at amo puerto rico manufacturing, inc. , anasco, puerto rico.
| Device | TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS |
| Classification Name | Lens, Multifocal Intraocular |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2009-04-28 |
| Decision Date | 2009-06-19 |
| PMA | P080010 |
| Supplement | S002 |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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 |
|---|---|---|
| P080010 | Original Filing | |
| S021 | 2022-11-09 | 30-day Notice |
| S020 | 2020-12-10 | 30-day Notice |
| S019 | ||
| S018 | 2019-02-26 | 30-day Notice |
| S017 | 2018-12-21 | 30-day Notice |
| S016 | 2018-12-21 | 30-day Notice |
| S015 | 2018-04-11 | 30-day Notice |
| S014 | 2017-09-28 | 30-day Notice |
| S013 | 2016-06-01 | 30-day Notice |
| S012 | 2015-12-18 | 30-day Notice |
| S011 | 2015-06-26 | 30-day Notice |
| S010 | 2013-11-26 | 30-day Notice |
| S009 | 2013-05-24 | 30-day Notice |
| S008 | 2012-04-23 | 30-day Notice |
| S007 | 2012-01-30 | 30-day Notice |
| S006 | ||
| S005 | 2010-04-01 | 30-day Notice |
| S004 | 2009-06-30 | 30-day Notice |
| S003 | 2009-06-09 | 30-day Notice |
| S002 | 2009-04-28 | Normal 180 Day Track No User Fee |
| S001 | 2009-01-27 | Normal 180 Day Track |