PMA P010013S058

Device: NOVASURE IMPEDANCE CONTROLLED EDOMETRIAL ABLATION SYSTEM
Applicant: Hologic, Inc.
PMA number: P010013
Supplement: S058
Product code: MNB
Decision date: 2014-10-28
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR DEVICE MODIFICATIONS, INCLUDING FLATTENING OF THE NVSRAM BATTERY CLIP AND ADDITION OF KAPTON TAPE TO THE NVSRAM BATTERY AND THE UI BOARD SHIELD TO OVERCOME A DEVICE ERROR OCCURRING IF CONTACT OF THESE COMPONENTS OCCURS.

Current openFDA PMA Record#

Device: NOVASURE IMPEDANCE CONTROLLED EDOMETRIAL ABLATION SYSTEM
Applicant: Hologic, Inc.
PMA number: P010013
Supplement: S058
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2014-10-28
Decision code: APPR
Date received: 2014-07-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DEVICE MODIFICATIONS, INCLUDING FLATTENING OF THE NVSRAM BATTERY CLIP AND ADDITION OF KAPTON TAPE TO THE NVSRAM BATTERY AND THE UI BOARD SHIELD TO OVERCOME A DEVICE ERROR OCCURRING IF CONTACT OF THESE COMPONENTS OCCURS.