PMA P140013S012
- Device
- Minerva Endometrial Ablation System
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S012
- Product code
- MNB
- Decision date
- 2021-02-17
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for a design change to the Check Valve located on the Disposable Handpiece.
Current openFDA PMA Record#
- Device
- Minerva Endometrial Ablation System
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S012
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2021-02-17
- Decision code
- APPR
- Date received
- 2020-11-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the Check Valve located on the Disposable Handpiece.