Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Minerva® Endometrial Ablation System
• Generic Name: Device, thermal ablation, endometrial
• Applicant: Axora Medical, Inc.; 1 Independent Dr. Suite 2300; Jacksonville, FL 32202
• PMA Number: P140013
• Supplement Number: S013
• Date Received: 12/23/2021
• Decision Date: 01/11/2022
• Product Code: MNB
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Transfer of the manifold assembly from the supplier to the contract manufacturer.