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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 Vapor System
Generic NameDevice, thermal ablation, endometrial
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP160047
Supplement NumberS015
Date Received09/29/2020
Decision Date10/20/2020
Withdrawal Date03/17/2026
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Use of a new coil bender tool during manufacturing to standardize the bend radius of the coil inlet tube for connection to the saline supply tube.
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