|Trade Name||HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|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.