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 of incorporation of a new double tray packaging configuration in order to accommodate physicians' ease of use. The new packaging configuration has currently been validated for a 5-year shelf life. In addition, an alternate sterilization site, sterigenics us llc, has been validated for the proposed packaging.
| Device | KAMRA INLAY |
| Generic Name | Implant, Corneal, Refractive |
| Applicant | CorneaGen |
| Date Received | 2015-10-28 |
| Decision Date | 2016-10-07 |
| PMA | P120023 |
| Supplement | S002 |
| Product Code | LQE |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |