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 revisions to the labeling to include the results of the post-approval study.
| Device | KAMRA INLAY |
| Generic Name | Implant, Corneal, Refractive |
| Applicant | CorneaGen |
| Date Received | 2017-01-25 |
| Decision Date | 2017-07-18 |
| PMA | P120023 |
| Supplement | S005 |
| Product Code | LQE |
| 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 | CorneaGen 1200 6th Avenue suite 300 seattle, WA 98101 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120023 | Original Filing | |
| S005 | 2017-01-25 | Normal 180 Day Track No User Fee |
| S004 | 2016-09-28 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2015-10-28 | Normal 180 Day Track |
| S001 | 2015-05-18 | Normal 180 Day Track No User Fee |