PMA P010013S051

Device: NOVASURE MODEL 10 RADIOFREQUENCY CONTROL UNIT
Applicant: Hologic, Inc.
PMA number: P010013
Supplement: S051
Product code: MNB
Decision date: 2014-04-22
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR A CHANGE TO THE NOVASURE RADIOFREQUENCY CONTROLLER (RFC) TO INCORPORATE A SOFTWARE-BASED GRAPHICAL USER INTERFACE (GUI), RESULTING IN THE MODEL 10 RFC.

Current openFDA PMA Record#

Device: NOVASURE MODEL 10 RADIOFREQUENCY CONTROL UNIT
Applicant: Hologic, Inc.
PMA number: P010013
Supplement: S051
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2014-04-22
Decision code: APPR
Date received: 2013-10-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE NOVASURE RADIOFREQUENCY CONTROLLER (RFC) TO INCORPORATE A SOFTWARE-BASED GRAPHICAL USER INTERFACE (GUI), RESULTING IN THE MODEL 10 RFC.