Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | EXABLATE 2000/2100 |
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 | S013 |
Date Received | 09/23/2013 |
Decision Date | 12/16/2013 |
Product Code |
NRZ |
Advisory Committee |
Obstetrics/Gynecology |
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. |
|
|