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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
Applicant
AEGEA MEDICAL , INC
2686 middlefield rd suite a
redwood city, CA 94063
PMA NumberP160047
Date Received10/25/2016
Decision Date06/14/2017
Product Code
MNB[ Registered Establishments with MNB ]
Docket Number 17M-3778
Notice Date 06/20/2017
Advisory Committee Obstetrics/Gynecology
Clinical Trials NCT01979861
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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