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.
| Device | TECNIS® Multifocal Foldable Posterior Chamber IOL |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP080010 Supplement NumberS021 Date Received11/09/2022 Decision Date12/06/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-09 |
| Decision Date | 2022-12-06 |
| PMA | P080010 |
| Supplement | S021 |
| 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. 31 Technology Drive suite 200 irvine, CA 92618 PMA NumberP080010 Supplement NumberS021 Date Received11/09/2022 Decision Date12/06/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement adding An Alternative Supplier For The Lens Case Assembly (LCA) |
| 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 |