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 change to the exablate system to comply with the european directive 2002/95/ec and 2011/65/eu in relation to restriction of hazardous substance (rohs).
| Device | EXABLATE |
| 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 | 2016-05-10 |
| Decision Date | 2016-08-26 |
| PMA | P110039 |
| Supplement | S006 |
| 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 |