KAMRA INLAY
FDA premarket approval P120023/S005 · decided 2017-07-18
Approval details
- PMA number
- P120023
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- KAMRA INLAY
- Generic name
- Implant, corneal, refractive
- Applicant
- Corneagen
- Date received
- 2017-01-25
- Decision date
- 2017-07-18
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Seattle, WA
- Statement
- Approval for revisions to the labeling to include the results of the post-approval study.
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