|
Device | EXABLATE |
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 | S010 |
Date Received | 09/13/2011 |
Decision Date | 12/08/2011 |
Product Code |
NRZ |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATION OF THE EXABLATE PLATFORM 1) SO THAT THE SAME PLATFORM CAN BE USED WITH MULTIPLE CRADLES; AND 2) TO ENABLE THE CRADLE THAT HAS THE CAPABILITY TO MOVE THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTIONS BE USED IN THE LOCKED POSITION FORCOMMERCIAL UTERINE FIBROID TREATMENT. |
Post-Approval Study | Show Report Schedule and Study Progress |