Mara Water Vapor System

FDA Premarket Approval P160047 S023

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 manufacturing process for the slide collar tips that replaces a multi-step fabrication process with the use of an injection molded component to form the tips

DeviceMara Water Vapor System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantAEGEA MEDICAL , INC
Date Received2021-03-25
Decision Date2021-04-21
PMAP160047
SupplementS023
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
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
00857379006030 P160047 006
00857379006023 P160047 006

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.