PMA P140013S013
- Device
- Minerva® Endometrial Ablation System
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S013
- Product code
- MNB
- Decision date
- 2022-01-11
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Transfer of the manifold assembly from the supplier to the contract manufacturer.
Current openFDA PMA Record#
- Device
- Minerva® Endometrial Ablation System
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S013
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2022-01-11
- Decision code
- OK30
- Date received
- 2021-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of the manifold assembly from the supplier to the contract manufacturer.