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PMA P140013S009

Device
Minerva Endometrial Ablation System
Applicant
Axora Medical, Inc.
PMA number
P140013
Supplement
S009
Product code
MNB
Decision date
2018-05-01
Classification
Device, Thermal Ablation, Endometrial
Generic name
Device, thermal ablation, endometrial
Approval order statement
Approval for the co-packaging of the Minerva Cervical Dilator with the Minerva Disposable Handpiece, modifications to the packaging design to accommodate said co-packaging, and the addition of a manufacturing supplier for the thermoformed tray and insert used in packaging said co-packaged devices.

Current openFDA PMA Record#

Device
Minerva Endometrial Ablation System
Applicant
Axora Medical, Inc.
PMA number
P140013
Supplement
S009
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2018-05-01
Decision code
APPR
Date received
2018-01-31
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the co-packaging of the Minerva Cervical Dilator with the Minerva Disposable Handpiece, modifications to the packaging design to accommodate said co-packaging, and the addition of a manufacturing supplier for the thermoformed tray and insert used in packaging said co-packaged devices.