Approval for the exablate model 4000 (neuro). The device is intended in the unilateral thalamotomy (ventralis intermedius) treatment of tremor-dominant parkinson’s disease with medication-refractory tremor. Patients must be at least age 30.
| Device | ExAblate |
| Classification Name | Mr-guided Focused Ultrasound System |
| Generic Name | Mr-guided Focused Ultrasound System |
| Applicant | InSightec |
| Date Received | 2018-03-07 |
| Decision Date | 2018-12-16 |
| Notice Date | 2019-01-25 |
| PMA | P150038 |
| Supplement | S006 |
| Product Code | POH |
| Docket Number | 19M-4780 |
| Advisory Committee | Neurology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | InSightec 5 Nahum Heth Street tirat-hacarmet 39120 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150038 | | Original Filing |
| S024 |
2022-10-12 |
Normal 180 Day Track No User Fee |
| S023 |
2022-08-05 |
Real-time Process |
| S022 | | |
| S021 |
2022-03-10 |
Real-time Process |
| S020 |
2022-03-08 |
30-day Notice |
| S019 | | |
| S018 | | |
| S017 | | |
| S016 | | |
| S015 | | |
| S014 |
2021-03-31 |
Panel Track |
| S013 |
2020-10-23 |
Normal 180 Day Track |
| S012 |
2019-08-08 |
Normal 180 Day Track |
| S011 |
2019-03-26 |
30-day Notice |
| S010 | | |
| S009 | | |
| S008 |
2018-07-23 |
Normal 180 Day Track |
| S007 |
2018-04-23 |
30-day Notice |
| S006 |
2018-03-07 |
Panel Track |
| S005 |
2018-02-20 |
Normal 180 Day Track |
| S004 |
2017-08-16 |
Normal 180 Day Track No User Fee |
| S003 |
2017-03-28 |
Normal 180 Day Track |
| S002 |
2017-01-17 |
Normal 180 Day Track |
| S001 |
2016-08-03 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices