PMA P140013S002

Device: MINERVA ENDOMETRIAL ABLATION SYSTEM
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S002
Product code: MNB
Decision date: 2016-08-30
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for a manufacturing site located at Minnetronix, Inc., 1635 Energy Park, Saint Paul, Minnesota, as a new manufacturing facility.

Current openFDA PMA Record#

Device: MINERVA ENDOMETRIAL ABLATION SYSTEM
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S002
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2016-08-30
Decision code: APPR
Date received: 2016-04-08
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Minnetronix, Inc., 1635 Energy Park, Saint Paul, Minnesota, as a new manufacturing facility.