PMA P010013S065

Device: NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Applicant: Hologic, Inc.
PMA number: P010013
Supplement: S065
Product code: MNB
Decision date: 2015-10-15
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY TO REFLECT THE FDA APPROVAL OF THE USE OF TRANSVAGINAL ULTRASOUND (TVU) AS AN ALTERNATE CONFIRMATION TEST FOR ESSURE.

Current openFDA PMA Record#

Device: NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Applicant: Hologic, Inc.
PMA number: P010013
Supplement: S065
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2015-10-15
Decision code: APPR
Date received: 2015-08-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol - OSB
Approval order statement: APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY TO REFLECT THE FDA APPROVAL OF THE USE OF TRANSVAGINAL ULTRASOUND (TVU) AS AN ALTERNATE CONFIRMATION TEST FOR ESSURE.