PMA P140013S015

Device: Minerva Endometrial Ablation System
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S015
Product code: MNB
Decision date: 2024-01-24
Classification: Obstetrics/Gynecology
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for an update to a manufacturing procedure to provide an additional requirement for the silicone tubing for the Minerva ES Handpiece.

Current openFDA PMA Record#

Device: Minerva Endometrial Ablation System
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S015
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2024-01-24
Decision code: APPR
Date received: 2024-01-03
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an update to a manufacturing procedure to provide an additional requirement for the silicone tubing for the Minerva ES Handpiece.