PMA P140013S007

Device: Minerva Endometrial Ablation System
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S007
Product code: MNB
Decision date: 2017-06-26
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for software changes to the Minerva Endometrial Ablation System (i.e., software modifications to 1) correct an error code during device start; 2) to redefine existing error codes to better align them with the observed device conditions; and 3) to add five software checks to the device).

Current openFDA PMA Record#

Device: Minerva Endometrial Ablation System
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S007
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2017-06-26
Decision code: APPR
Date received: 2017-04-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for software changes to the Minerva Endometrial Ablation System (i.e., software modifications to 1) correct an error code during device start; 2) to redefine existing error codes to better align them with the observed device conditions; and 3) to add five software checks to the device).