EXABLATE 2000 SYSTEM

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

FDA Premarket Approval P040003 S017

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 updates to the software to change the operating system and fix minor software defects.

• Device: EXABLATE 2000 SYSTEM
• Classification Name: Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided
• Generic Name: Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided
• Applicant: INSIGHTEC, LTD
• Date Received: 2016-04-04
• Decision Date: 2016-06-27
• PMA: P040003
• Supplement: S017
• Product Code: NRZ
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: INSIGHTEC, LTD 4851 Lbj Frwy, Ste 400 dallas, TX 75244

Supplemental Filings

Supplement Number	Date	Supplement Type
P040003		Original 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 ID	PMA	Supp
07290015461047	P040003	017