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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 Ablation System, Mara Water Vapor Probe Procedure Kit, Mara Water Vapor Probe, Mara Supply and Drain Ac
Generic NameDevice, thermal ablation, endometrial
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP160047
Supplement NumberS007
Date Received10/10/2019
Decision Date11/04/2019
Withdrawal Date03/17/2026
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to change the trade name of the device from the AEGEA Vapor System to the MARA Water Vapor Ablation System.
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