Minerva Endometrial Ablation System
FDA premarket approval P140013/S010 · decided 2018-06-21
Approval details
- PMA number
- P140013
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Minerva Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2018-04-09
- Decision date
- 2018-06-21
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- approval for software modifications to the RF controller and the implementation of additional software checks
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