PMA P000040S004

Device: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
Applicant: Axora Medical, Inc.
PMA number: P000040
Supplement: S004
Product code: MNB
Decision date: 2004-02-24
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR UPDATED LABELING THAT REFLECTS THE 2 AND 3 YEAR PATIENT FOLLOW-UP DATA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTZ SYSTEM AND IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.

Current openFDA PMA Record#

Device: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
Applicant: Axora Medical, Inc.
PMA number: P000040
Supplement: S004
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2004-02-24
Decision code: APPR
Date received: 2003-08-25
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATED LABELING THAT REFLECTS THE 2 AND 3 YEAR PATIENT FOLLOW-UP DATA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTZ SYSTEM AND IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.