EXABLATE 2000/2100
FDA premarket approval P110039/S004 · decided 2013-12-17
Approval details
- PMA number
- P110039
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXABLATE 2000/2100
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec
- Date received
- 2013-09-23
- Decision date
- 2013-12-17
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- APPROVAL FOR A MINOR SOFTWARE CHANGE OF THE EXABLATE SYSTEM TO ADDRESS THE MICRO-SWITCH ERROR.
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