PMA P140013S010
- Device
- Minerva Endometrial Ablation System
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S010
- Product code
- MNB
- Decision date
- 2018-06-21
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- approval for software modifications to the RF controller and the implementation of additional software checks
Current openFDA PMA Record#
- Device
- Minerva Endometrial Ablation System
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S010
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2018-06-21
- Decision code
- APPR
- Date received
- 2018-04-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for software modifications to the RF controller and the implementation of additional software checks