PMA P140013S006
- Device
- Minerva Endometrial Ablation System
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S006
- Product code
- MNB
- Decision date
- 2017-08-07
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for labeling changes to update the clinical study results to reflect the final 2- and 3-year follow-up results from the Minerva Single-Arm study, as well as the 1-year follow-up results from the Minerva Randomized Control Trial.
Current openFDA PMA Record#
- Device
- Minerva Endometrial Ablation System
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S006
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2017-08-07
- Decision code
- APPR
- Date received
- 2017-02-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling changes to update the clinical study results to reflect the final 2- and 3-year follow-up results from the Minerva Single-Arm study, as well as the 1-year follow-up results from the Minerva Randomized Control Trial.