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 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a change to the pressure sensor thermal offset determination process and a change to align the device lumen patency test sequence.

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
ApplicantAEGEA MEDICAL , INC
Date Received2018-08-31
Decision Date2018-11-29
PMAP160047
SupplementS003
Product CodeMNB
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address AEGEA MEDICAL , INC 2686 Middlefield Rd Suite A redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P160047Original 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 IDPMASupp
00888937026887 P160047 000
00888937026870 P160047 000
00857379006030 P160047 006
00857379006023 P160047 006

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