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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEXABLATE DEVICE
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantINSIGHTEC, LTD
4851 LBJ FRWY, STE 400
DALLAS, TX 75244
PMA NumberP040003
Supplement NumberS011
Date Received04/09/2012
Decision Date05/01/2012
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES INCLUDING: 1) DELETION OF THE COMMENT (OUTCOMES OF 10 PREGNANCIES ARE PENDING AS OF AUGUST 2008, AND OUTCOME OF ONE PREGNANCY IS UNKNOWN.) AND ADDITION OF DEEP VEIN THROMBOSIS UNDER THE SECTION ENTITLED OTHER ADVERSE EVENTS.
Post-Approval StudyShow Report Schedule and Study Progress
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