|Trade Name||HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for 1) addition of the linear flash card memory to the central processing board; 2) temperature controller pid settings/increase in cycle time programmed into heater logic and controller board; and 3) addition of components to the level sensor board.