PMA P140013S005

Device: MINERVA ENDOMETRIAL ABLATION SYSTEM
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S005
Product code: MNB
Decision date: 2017-05-15
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for the addition of a CO2 extension tube and sheath marking to the Minerva Handpiece and software modifications to the gas management module in the RF controller.

Current openFDA PMA Record#

Device: MINERVA ENDOMETRIAL ABLATION SYSTEM
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S005
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2017-05-15
Decision code: APPR
Date received: 2016-10-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of a CO2 extension tube and sheath marking to the Minerva Handpiece and software modifications to the gas management module in the RF controller.