Minerva Endometrial Ablation System
by Axora Medical, Inc. PMA
Active
PMA P140013
Overview
The Minerva Endometrial Ablation System is a Class III thermal ablation device designed for endometrial ablation. It is indicated for the ablation of the endometrial lining in pre-menopausal women with menorrhagia caused by benign conditions, where childbearing is complete. The system employs simultaneous thermal energy modalities to achieve consistent tissue coverage.
This device is supplied sterile and intended for single-use. It is regulated under an FDA Premarket Approval (PMA) and falls under the Obstetrics/Gynecology advisory committee category. The system is engineered for use in clinical settings and requires proper handling and storage as per manufacturer guidelines to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP140013 | Date27 Jul 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- Device, thermal ablation, endometrial
- PMA Number
- FDA Product Code
- MNB
- Device Class
- Class III
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- APPR Approved
Other devices from Axora Medical, Inc.
Questions
What is the Minerva Endometrial Ablation System used for in clinical practice?
The Minerva Endometrial Ablation System is specifically designed for endometrial ablation, which is the removal or destruction of the endometrial lining in the uterus. It is intended for pre-menopausal women who experience menorrhagia (excessive menstrual bleeding) due to benign conditions and have completed childbearing. The system uses thermal energy to achieve consistent ablation of the endometrial lining, helping to reduce or eliminate heavy bleeding.
Is the Minerva Endometrial Ablation System intended for reuse or is it single-use?
The Minerva Endometrial Ablation System is explicitly supplied sterile and intended for **single-use only**. This design ensures patient safety and maintains sterility, as reuse could compromise its integrity and potentially introduce infection risks.
How should the Minerva Endometrial Ablation System be stored to preserve its functionality?
The device must be stored according to the manufacturer’s guidelines to maintain sterility and functionality. Since it is sterile upon supply and single-use, it should be kept in its original packaging until use, protected from contamination, moisture, and extreme temperatures. Improper storage could compromise its performance or sterility.
What regulatory pathway does the Minerva Endometrial Ablation System follow?
The Minerva Endometrial Ablation System is regulated under the **FDA Premarket Approval (PMA)** pathway, which is required for Class III devices. This approval was granted through the Obstetrics/Gynecology advisory committee, confirming its compliance with rigorous safety and effectiveness standards for endometrial ablation procedures.