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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
ApplicantNOVACEPT, INC.
PMA NumberP010013
Supplement NumberS002
Date Received05/08/2002
Decision Date06/05/2002
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modifications to the manufacturing processes for the novasure disposable device, including injection molding of the plastic components, incorporation of the non-conducting lines of the array into the peak ii knitting process, and the incorporation of three separate tubes into a single multi-lumen extrusion.
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