|
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 | S003 |
Date Received | 06/28/2013 |
Decision Date | 08/06/2013 |
Product Code |
NRZ |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |