|
Device | EXABLATE 2000/2100 |
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 | S004 |
Date Received | 09/23/2013 |
Decision Date | 12/17/2013 |
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 A MINOR SOFTWARE CHANGE OF THE EXABLATE SYSTEM TO ADDRESS THE MICRO-SWITCH ERROR. |