|
Device | InSightec ExAblate System |
Generic Name | Ablation system, high intensity focused ultrasound (HIFU), MR-guided |
Applicant | INSIGHTEC, LTD 4851 LBJ FRWY, STE 400 DALLAS, TX 75244 |
PMA Number | P040003 |
Supplement Number | S019 |
Date Received | 09/28/2016 |
Decision Date | 10/28/2016 |
Product Code |
NRZ |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of adenomyosis to the list of conditions for which the safety and effectiveness of ExAblate have not been evaluated. |