Minerva Endometrial Ablation System
FDA premarket approval P140013/S009 · decided 2018-05-01
Approval details
- PMA number
- P140013
- Supplement
- S009
- 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
- 2018-01-31
- Decision date
- 2018-05-01
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for the co-packaging of the Minerva Cervical Dilator with the Minerva Disposable Handpiece, modifications to the packaging design to accommodate said co-packaging, and the addition of a manufacturing supplier for the thermoformed tray and insert used in packaging said co-packaged devices.
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