EXABLATE 2000/2100 1.5 AND 3T
FDA premarket approval P040003/S009 · decided 2011-08-09
Approval details
- PMA number
- P040003
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- 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.
- Date received
- 2010-07-26
- Decision date
- 2011-08-09
- Days to decision
- 379 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- APPROVAL FOR UPDATED LABELING INCLUDING LONG-TERM DATA FROM THE POST-APPROVAL STUDY.
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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 |