PMA P120023S004
- Device
- KAMRA INLAY
- Applicant
- Corneagen
- PMA number
- P120023
- Supplement
- S004
- Product code
- LQE
- Decision date
- 2017-05-16
- Generic name
- Implant, corneal, refractive
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- KAMRA INLAY
- Applicant
- Corneagen
- PMA number
- P120023
- Supplement
- S004
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2017-05-16
- Decision code
- APPR
- Date received
- 2016-09-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.