Premarket Approval (PMA)

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.

• Device: Mara Water Vapor Ablation System
• Generic Name: Device, thermal ablation, endometrial
• Applicant: CooperSurgical, Inc.; 95 Corporate Dr.; Trumbull, CT 06611
• PMA Number: P160047
• Supplement Number: S030
• Date Received: 05/08/2023
• Decision Date: 06/30/2023
• Withdrawal Date: 03/17/2026
• Product Code: MNB
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for changes in the software test values (RF test time and Middle Balloon test pressure) for verification and validation tests.