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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 IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal endometrial ablation device
ApplicantHOLOGIC, INC.
PMA NumberP010013
Supplement NumberS041
Date Received09/07/2011
Decision Date02/01/2013
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of labeling changes pertaining to the use of novasure impedance controlled endometrial ablation in patients who have micro-inserts from the essure system for permanent birth control trailing into the endometrial cavity from the fallopian tubes.
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