EXABLATE 2000, VERSION 4.22
FDA premarket approval P040003/S004 · decided 2007-08-02
Approval details
- PMA number
- P040003
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXABLATE 2000, VERSION 4.22
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2007-04-06
- Decision date
- 2007-08-02
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- APPROVAL FOR SEVERAL HARDWARE ENHANCEMENTS AND SOFTWARE ERROR CORRECTIONS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |