PMA supplement
P040003 S009: EXABLATE 2000/2100 1.5 AND 3T
FDA PMA supplement · Normal 180 Day Track No User Fee · Insightec, Ltd.
Key facts
| Original PMA | P040003 |
|---|---|
| Supplement number | S009 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | EXABLATE 2000/2100 1.5 AND 3T |
| Generic name | Ablation system, high intensity focused ultrasound (HIFU), MR-guided |
| Applicant | Insightec, Ltd. |
| Product code | NRZ |
| Received date | Jul 26, 2010 |
| Decision date | Aug 9, 2011 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: