DevicePMAs@therightstef:P160047_S000 / 0-11 JSONTXT

Approval for the AEGEA Vapor System (including the AEGEA Vapor Probe Procedure Kit, AEGEA Vapor Generator, and AEGEA Vapor Generator Accessory Kit). This device is indicated to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes in whom childbearing is complete.

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PMA_MER 1 (1)