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.
| Device | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) |
| Generic Name | Mr-guided Focused Ultrasound System |
| Applicant | InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS023 Date Received08/05/2022 Decision Date11/02/2022 Product Code POH Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-08-05 |
| Decision Date | 2022-11-02 |
| PMA | P150038 |
| Supplement | S023 |
| Product Code | POH |
| Advisory Committee | Neurology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | InSightec 5 Nahum Heth Street tirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS023 Date Received08/05/2022 Decision Date11/02/2022 Product Code POH Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of Another Sterile Disposable Head Ring Screws (DHRS) Option, Manufactured By INSIGHTEC And Marketed Under A Name PFK (Patient Fixation Kit), As An Accessory To Exablate Neuro System |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 07290019402466 | P150038 | 023 |
| 07290019402442 | P150038 | 023 |