|
Device | EXABLATE |
Generic Name | Ablation system, high intensity focused ultrasound (HIFU), MR-guided |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-CARMEL 39120 |
PMA Number | P110039 |
Supplement Number | S006 |
Date Received | 05/10/2016 |
Decision Date | 08/26/2016 |
Product Code |
NRZ |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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). |