EXABLATE SYSTEM
FDA premarket approval P040003/S012 · decided 2012-09-07
Approval details
- PMA number
- P040003
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXABLATE SYSTEM
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2012-08-13
- Decision date
- 2012-09-07
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- CHANGE IN THE MANUFACTURING OF THE TRANSDUCER FOR THE EXABLATE SYSTEM FROM A CONTRACT MANUFACTURER TO THE IN-HOUSE FACILITY.
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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 |