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 modifying the physician and patient labeling to include the results from the new enrollment post-approval study.
| Device | ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL) |
| Classification Name | Lens, Intraocular, Phakic |
| Generic Name | Lens, Intraocular, Phakic |
| Applicant | OPHTEC BV |
| Date Received | 2017-01-31 |
| Decision Date | 2018-08-20 |
| PMA | P030028 |
| Supplement | S004 |
| Product Code | MTA |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OPHTEC BV 6421 Congress Ave,suite 112 boca Raton, FL 33487 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030028 | Original Filing | |
| S009 | 2022-02-08 | 30-day Notice |
| S008 | 2019-02-06 | Real-time Process |
| S007 | ||
| S006 | 2018-09-18 | 30-day Notice |
| S005 | 2017-01-23 | Normal 180 Day Track No User Fee |
| S004 | 2017-01-31 | Normal 180 Day Track No User Fee |
| S003 | 2012-01-05 | 30-day Notice |
| S002 | 2010-10-29 | 30-day Notice |
| S001 | 2009-11-25 | Normal 180 Day Track No User Fee |