This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the kamra inlay. The kamra inlay is indicated for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0. 50 d to -0. 75 d with less than or equal to 0. 75 d of refractivecylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1. 00 d to +2. 50 d of reading add.
| Device | KAMRA INLAY |
| Generic Name | Implant, Corneal, Refractive |
| Applicant | CorneaGen |
| Date Received | 2012-12-12 |
| Decision Date | 2015-04-17 |
| Notice Date | 2015-04-29 |
| PMA | P120023 |
| Supplement | S |
| Product Code | LQE |
| Docket Number | 15M-1326 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CorneaGen 1200 6th Avenue suite 300 seattle, WA 98101 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |