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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEXABLATE
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
ApplicantINSIGHTEC
PMA NumberP110039
Date Received12/05/2011
Decision Date10/18/2012
Product Code
NRZ[ Registered Establishments with NRZ ]
Docket Number 12M-1085
Notice Date 11/08/2012
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00656305
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 
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