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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.
 
Trade NameNOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal endometrial ablation device
ApplicantHOLOGIC, INC.
PMA NumberP010013
Supplement NumberS025
Date Received08/17/2009
Decision Date10/16/2009
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the changes to the sheath and cervical collar of the novasure disposable device.
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