FDA.reportPublic FDA data

PMA P010013S070

Device
NovaSure Impedance Controlled Endometrail Ablation Device
Applicant
Hologic, Inc.
PMA number
P010013
Supplement
S070
Product code
MNB
Decision date
2018-05-17
Classification
Device, Thermal Ablation, Endometrial
Generic name
Device, thermal ablation, endometrial
Approval order statement
Addition of the second supplier for the Thumb Pusher Component of the Novasure Disposable Device and the addition of the second supplier for the CO2 Cartridge 5-Pack Assembly.

Current openFDA PMA Record#

Device
NovaSure Impedance Controlled Endometrail Ablation Device
Applicant
Hologic, Inc.
PMA number
P010013
Supplement
S070
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2018-05-17
Decision code
OK30
Date received
2018-04-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of the second supplier for the Thumb Pusher Component of the Novasure Disposable Device and the addition of the second supplier for the CO2 Cartridge 5-Pack Assembly.