|Trade Name||NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Generic Name||thermal endometrial ablation device|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revised instructions for use, including results from the three-year follow up, improved consistency, and a revision to the contraindications regarding long-term medical therapy.