|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|| location change: packager|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at cytyc corporation, marlborough, massachusetts. The manufacturing steps to be performed at marlborough, massachusetts will be the final test, labeling, packaging and inspection/release operations associated with the radio frequency (rf) controller.