InSightec ExAblate System
FDA premarket approval P040003/S019 · decided 2016-10-28
Approval details
- PMA number
- P040003
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- InSightec ExAblate System
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2016-09-28
- Decision date
- 2016-10-28
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- Approval for the addition of adenomyosis to the list of conditions for which the safety and effectiveness of ExAblate have not been evaluated.
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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 |