PMA P120023S005
- Device
- KAMRA INLAY
- Applicant
- Corneagen
- PMA number
- P120023
- Supplement
- S005
- Product code
- LQE
- Decision date
- 2017-07-18
- Generic name
- Implant, corneal, refractive
- Approval order statement
- Approval for revisions to the labeling to include the results of the post-approval study.
Current openFDA PMA Record#
- Device
- KAMRA INLAY
- Applicant
- Corneagen
- PMA number
- P120023
- Supplement
- S005
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2017-07-18
- Decision code
- APPR
- Date received
- 2017-01-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for revisions to the labeling to include the results of the post-approval study.