DevicePMAs@therightstef:P000040_S004 / 61-68 JSONTXT

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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PMA_MER 1 (1)