EXABLATE DEVICE

Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided

FDA Premarket Approval P040003 S011

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.

Pre-market Approval Supplement Details

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.

DeviceEXABLATE DEVICE
Classification NameAblation System, High Intensity Focused Ultrasound (hifu), Mr-guided
Generic NameAblation System, High Intensity Focused Ultrasound (hifu), Mr-guided
ApplicantINSIGHTEC, LTD
Date Received2012-04-09
Decision Date2012-05-01
PMAP040003
SupplementS011
Product CodeNRZ
Advisory CommitteeObstetrics/Gynecology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address INSIGHTEC, LTD 4851 Lbj Frwy, Ste 400 dallas, TX 75244

Supplemental Filings

Supplement NumberDateSupplement Type
P040003Original Filing
S021 2018-04-26 Real-time Process
S020
S019 2016-09-28 Special (immediate Track)
S018 2016-05-10 Real-time Process
S017 2016-04-04 Real-time Process
S016 2015-04-07 Normal 180 Day Track
S015 2015-03-04 Normal 180 Day Track
S014 2014-02-26 Normal 180 Day Track No User Fee
S013 2013-09-23 Real-time Process
S012 2012-08-13 30-day Notice
S011 2012-04-09 Special (immediate Track)
S010 2011-09-13 Normal 180 Day Track
S009 2010-07-26 Normal 180 Day Track No User Fee
S008 2010-07-01 Real-time Process
S007 2010-01-22 Normal 180 Day Track No User Fee
S006 2009-06-05 Normal 180 Day Track
S005 2008-09-19 Normal 180 Day Track
S004 2007-04-06 Normal 180 Day Track
S003
S002 2006-07-17 Normal 180 Day Track
S001 2005-08-25 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
07290015461047 P040003 017

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