KAMRA INLAY
FDA premarket approval P120023/S004 · decided 2017-05-16
Approval details
- PMA number
- P120023
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- KAMRA INLAY
- Generic name
- Implant, corneal, refractive
- Applicant
- Corneagen
- Date received
- 2016-09-28
- Decision date
- 2017-05-16
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Seattle, WA
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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