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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NameEXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM
Classification Nameultrasound,hyperthermia, cancer treatment
Generic Namemagnetic resonance guidedfocused ultrasound
ApplicantINSIGHTEC, INC.
PMA NumberP040003
Supplement NumberS001
Date Received08/25/2005
Decision Date12/30/2005
Product Code
LSY[ Registered Establishments with LSY ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at insightec image guided treatment ltd. , tirat carmel, israel.
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