EXABLATE 2100 SYSTEM

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

FDA Premarket Approval P040003 S006

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 addition of enhanced sonication, a detachable cradle, and several other modifications to the exablate 2000 system. The device, as modified, will be marketed under the trade name exablate 2100 and is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure and whose uterine size is less than 24 weeks. Patients should have completed child bearing.

• Device: EXABLATE 2100 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: 2009-06-05
• Decision Date: 2009-12-22
• PMA: P040003
• Supplement: S006
• Product Code: NRZ
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Normal 180 Day Track
• 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
• Post-Approval Study: Show Report Schedule and Study Progress

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