EXABLATE
FDA premarket approval P040003/S016 · decided 2015-10-05
Approval details
- PMA number
- P040003
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXABLATE
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2015-04-07
- Decision date
- 2015-10-05
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- APPROVAL FOR CHANGES TO THE SOFTWARE OF THE EXABLATE SYSTEM INCLUDING ENABLING MOVEMENT OF THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTION. THE MODIFIED DEVICE IS REFERRED TO AS THE EXABLATE 2100 V1.1 WITH SOFTWARE VERSION 6.5.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (K231378) | Insightec, Ltd. | 2023-10-30 |