|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||HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling for post approval study|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the labeling to reflect the results of the post-approval study.