Mara Water Vapor Ablation System, Mara Water Vapor Probe Procedure Kit, Mara Water Vapor Probe, Mara Supply and Drain Ac

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P160047 S007

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 to change the trade name of the device from the aegea vapor system to the mara water vapor ablation system.

DeviceMara Water Vapor Ablation System, Mara Water Vapor Probe Procedure Kit, Mara Water Vapor Probe, Mara Supply and Drain Ac
Classification NameDevice, Thermal Ablation, Endometrial
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantAEGEA MEDICAL , INC
Date Received2019-10-10
Decision Date2019-11-04
PMAP160047
SupplementS007
Product CodeMNB
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
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

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