|Trade Name||THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Generic Name||thermal ballo0n endometrial ablation|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revised labeling that includes three-year post-treatment information, as required as a condition of approval for the original pma application.