|Trade Name||HER OPTION CRYOABLATION THERAPY SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Generic Name||device, thermal ablation, endometrial|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the quality tests used to evaluate the thermocouple wiring in the disposable control unit (dcu) and for a change to the labeling to include additional precautions/instructions for the year.