InSightec ExAblate System

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

FDA Premarket Approval P040003 S019

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 the addition of adenomyosis to the list of conditions for which the safety and effectiveness of exablate have not been evaluated.

DeviceInSightec ExAblate System
Classification NameAblation System, High Intensity Focused Ultrasound (hifu), Mr-guided
Generic NameAblation System, High Intensity Focused Ultrasound (hifu), Mr-guided
ApplicantINSIGHTEC, LTD
Date Received2016-09-28
Decision Date2016-10-28
PMAP040003
SupplementS019
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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