|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 Name||NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Generic Name||thermal endometrial ablation device|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the leak test performed on the rf controller manifold subassembly.