This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the exablate system, model 2000/2100 /2100 vi. This device is indicated for pain palliation of metastatic bone cancer in patients 18 years of age or older who are suffering from bone pain due to metastatic disease and who arc failures of standard radiation therapy, or not candidates for, or refused radiation therapy. The bone tumor to be treated must be visible on non-contrast mr and device accessible.
| 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 |
| Date Received | 2011-12-05 |
| Decision Date | 2012-10-18 |
| Notice Date | 2012-11-08 |
| PMA | P110039 |
| Supplement | S |
| Product Code | NRZ |
| Docket Number | 12M-1085 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | InSightec 5 Nahum Heth Street tirat-carmel 39120 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110039 | Original Filing | |
| S010 | 2018-04-26 | Real-time Process |
| S009 | ||
| S008 | 2017-09-22 | Normal 180 Day Track |
| S007 | ||
| S006 | 2016-05-10 | Real-time Process |
| S005 | 2016-04-04 | Real-time Process |
| S004 | 2013-09-23 | Real-time Process |
| S003 | 2013-06-28 | Normal 180 Day Track No User Fee |
| S002 | 2012-11-06 | Normal 180 Day Track No User Fee |
| S001 | 2012-11-06 | Normal 180 Day Track No User Fee |