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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceMARA Water Vapor System
Generic NameDevice, thermal ablation, endometrial
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP160047
Supplement NumberS005
Date Received06/19/2019
Decision Date01/08/2020
Withdrawal Date03/17/2026
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of changes to the instructions for use and patient labeling to include the results of the Post-Ablation Cavity Evaluation (PACE) study, which evaluated the ability to assess the uterine cavity more than three-years post endometrial ablation with the MARA Water Vapor System
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