Mara Water Vapor Ablation System

FDA Premarket Approval P160047 S025

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 of changes made to mara water vapor probe handle, handle plug, and protective sheath assembly

DeviceMara Water Vapor Ablation System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantCooperSurgical, Inc.
Date Received2021-09-28
Decision Date2021-10-29
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CooperSurgical, Inc. 95 Corporate Drive trumbull, CT 06611

Supplemental Filings

Supplement NumberDateSupplement Type
P160047Original Filing
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
S020 2021-01-06 30-day Notice
S019 2020-12-22 30-day Notice
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
S007 2019-10-10 Normal 180 Day Track No User Fee
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


Device IDPMASupp
00857379006030 P160047 006
00857379006023 P160047 006

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