PMA P140013S017

Device: Minerva ES Endometrial Ablation System
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S017
Product code: MNB
Decision date: 2024-12-05
Classification: Obstetrics/Gynecology
Generic name: Device, thermal ablation, endometrial
Approval order statement: approval for a process change to reduce occurrence of error codes that may occur during device use and labeling changes to clarify troubleshooting steps

Current openFDA PMA Record#

Device: Minerva ES Endometrial Ablation System
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S017
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2024-12-05
Decision code: APPR
Date received: 2024-11-12
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a process change to reduce occurrence of error codes that may occur during device use and labeling changes to clarify troubleshooting steps