EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM
FDA premarket approval P040003/S001 · decided 2005-12-30
Approval details
- PMA number
- P040003
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM
- Generic name
- Ultrasound, hyperthermia, cancer treatment
- Applicant
- Insightec, Ltd.
- Date received
- 2005-08-25
- Decision date
- 2005-12-30
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- LSY
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT INSIGHTEC IMAGE GUIDED TREATMENT LTD., TIRAT CARMEL, ISRAEL.
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 |