AEGEA Water Vapor Ablation System

FDA Premarket Approval P160047 S016

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 changes being made to replace a manual calibration process for the mara console with an automated calibration process

DeviceAEGEA Water Vapor Ablation System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantAEGEA MEDICAL , INC
Date Received2020-10-01
Decision Date2020-11-10
PMAP160047
SupplementS016
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
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
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006030 P160047 006
00857379006023 P160047 006
00857379006023 P160047 006

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