PMA P010013S059

Device: NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM/ ABLATION SYSTEM WITH SURESOUND UTERINE SOUND
Applicant: Hologic, Inc.
PMA number: P010013
Supplement: S059
Product code: MNB
Decision date: 2014-09-09
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: STERILIZATION PROCESS CHANGE TO REDUCE THE AERATION TIME IN THE STERILIZATION PROCESS.

Current openFDA PMA Record#

Device: NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM/ ABLATION SYSTEM WITH SURESOUND UTERINE SOUND
Applicant: Hologic, Inc.
PMA number: P010013
Supplement: S059
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2014-09-09
Decision code: OK30
Date received: 2014-08-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: STERILIZATION PROCESS CHANGE TO REDUCE THE AERATION TIME IN THE STERILIZATION PROCESS.