PMA P140013S001
- Device
- MINERVA ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S001
- Product code
- MNB
- Decision date
- 2016-02-23
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for a software modification to the Minerva RF Controller software to reduce the occurrence of false error codes.
Current openFDA PMA Record#
- Device
- MINERVA ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S001
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2016-02-23
- Decision code
- APPR
- Date received
- 2015-12-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software modification to the Minerva RF Controller software to reduce the occurrence of false error codes.