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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
CooperSurgical, Inc.
95 corporate dr.
trumbull, CT 06611
PMA NumberP000032
Supplement NumberS031
Date Received12/11/2009
Decision Date01/07/2010
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the final tester of the device to better monitor test results as well as changes in the test methods used in the final tester.