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.
Approval for a minor software change of the exablate system to address the micro-switch error.
| Device | EXABLATE 2000/2100 |
| 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 | 2013-09-23 |
| Decision Date | 2013-12-17 |
| PMA | P110039 |
| Supplement | S004 |
| Product Code | NRZ |
| Advisory Committee | General & Plastic Surgery |
| 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-carmel 39120 |
| 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 |