KAMRA INLAY
FDA premarket approval P120023/S002 · decided 2016-10-07
Approval details
- PMA number
- P120023
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KAMRA INLAY
- Generic name
- Implant, corneal, refractive
- Applicant
- Corneagen
- Date received
- 2015-10-28
- Decision date
- 2016-10-07
- Days to decision
- 345 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Seattle, WA
- Statement
- Approval of incorporation of a new double tray packaging configuration in order to accommodate physicians' ease of use. The new packaging configuration has currently been validated for a 5-year shelf life. In addition, an alternate sterilization site, Sterigenics US LLC, has been validated for the proposed packaging.
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