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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEXABLATE
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantInSightec
5 NAHUM HETH STREET
TIRAT-CARMEL 39120
PMA NumberP110039
Date Received12/05/2011
Decision Date10/18/2012
Product Code NRZ 
Docket Number 12M-1085
Notice Date 11/08/2012
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00656305
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE EXABLATE SYSTEM, MODEL 2000/2100 /2100 VI. THIS DEVICE IS INDICATED FOR PAIN PALLIATION OF METASTATIC BONE CANCER IN PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE SUFFERING FROM BONE PAIN DUE TO METASTATIC DISEASE AND WHO ARC FAILURES OF STANDARD RADIATION THERAPY, OR NOT CANDIDATES FOR, OR REFUSED RADIATION THERAPY. THE BONE TUMOR TO BE TREATED MUST BE VISIBLE ON NON-CONTRAST MR AND DEVICE ACCESSIBLE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S008 S010 
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