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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
Generic NameDevice, thermal ablation, endometrial
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP160047
Supplement NumberS021
Date Received03/22/2021
Decision Date06/09/2021
Withdrawal Date03/17/2026
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to device software, design modifications, and updated labeling to reflect the software changes.
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