Approval for changes to the software of the exablate system including enabling movement of the transducer in the anterior and posterior direction. The modified device is referred to as the exablate 2100 v1. 1 with software version 6. 5.
| Device | EXABLATE |
| 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 | 2015-04-07 |
| Decision Date | 2015-10-05 |
| PMA | P040003 |
| Supplement | S016 |
| 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