AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P160047

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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.

• Device: AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT
• Classification Name: Device, Thermal Ablation, Endometrial
• Generic Name: Device, Thermal Ablation, Endometrial
• Applicant: AEGEA MEDICAL , INC
• Date Received: 2016-10-25
• Decision Date: 2017-06-14
• Notice Date: 2017-06-20
• PMA: P160047
• Supplement: S
• Product Code: MNB
• Docket Number: 17M-3778
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review: No
• Combination Product: No
• Applicant Address: AEGEA MEDICAL , INC 2686 Middlefield Rd Suite A redwood City, CA 94063
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P160047		Original Filing
S028	2022-12-21	30-day Notice
S027	2022-11-14	30-day Notice
S026	2022-01-05	30-day Notice
S025	2021-09-28	30-day Notice
S024	2021-04-01	30-day Notice
S023	2021-03-25	30-day Notice
S022	2021-03-23	30-day Notice
S021
S020	2021-01-06	30-day Notice
S019	2020-12-22	30-day Notice
S018
S017	2020-10-01	30-day Notice
S016	2020-10-01	30-day Notice
S015	2020-09-29	30-day Notice
S014	2020-09-25	30-day Notice
S013	2020-07-06	Real-time Process
S012	2020-06-22	30-day Notice
S011	2020-06-05	30-day Notice
S010	2020-04-07	30-day Notice
S009
S008
S007	2019-10-10	Normal 180 Day Track No User Fee
S006
S005
S004	2018-12-18	Normal 180 Day Track No User Fee
S003	2018-08-31	Normal 180 Day Track
S002	2018-08-27	30-day Notice
S001	2018-03-05	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00888937026887	P160047	000
00888937026870	P160047	000
00857379006030	P160047	006
00857379006023	P160047	006