The exablate neuro is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic parkinson’s disease with medication-refractory moderate to severe motor complications as an adjunct to parkinson’s disease medication treatment. Patients must be at least age 30. The designated area in the brain responsible for the movement disorder symptoms [globus pallidus (gpi)] must be identified and accessible for targeted thermal ablation by the exablate device.
| Device | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) |
| Generic Name | Mr-guided Focused Ultrasound System |
| Applicant | InSightec |
| Date Received | 2021-03-31 |
| Decision Date | 2021-10-29 |
| PMA | P150038 |
| Supplement | S014 |
| Product Code | POH |
| 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 |
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