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 NumberS024 Date Received10/12/2022 Decision Date11/11/2022 Product Code POH Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-10-12 |
| Decision Date | 2022-11-11 |
| PMA | P150038 |
| Supplement | S024 |
| Product Code | POH |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | InSightec 5 Nahum Heth Street tirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS024 Date Received10/12/2022 Decision Date11/11/2022 Product Code POH Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P150038/S006 |
| 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 |