Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console

FDA Premarket Approval P160047 S024

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

A change to the supply chain for manufacturing of the mara console to add additional qualified suppliers for components used in its assembly

DeviceMara Water Vapor Ablation System, Mara Water Vapor System, Mara Console
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantAEGEA MEDICAL , INC
Date Received2021-04-01
Decision Date2021-04-19
PMAP160047
SupplementS024
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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