HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P000040/S004 · decided 2004-02-24
Approval details
- PMA number
- P000040
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2003-08-25
- Decision date
- 2004-02-24
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- 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.
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