EXABLATE
FDA premarket approval P040003/S015 · decided 2015-08-31
Approval details
- PMA number
- P040003
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXABLATE
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2015-03-04
- Decision date
- 2015-08-31
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE STATEMENT, PHYSICIAN LABELING, AND PATIENT LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXABLATE MAGNETIC RESONANCE GUIDED FOCUSED ULTRASOUND SYSTEM AND IS INDICATED TO ABLATE UTERINE FIBROID TISSUE IN PRE- OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE AND WHOSE UTERINE SIZE IS LESS THAN 24 WEEKS.
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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 |