EXABLATE
FDA premarket approval P110039 · decided 2012-10-18
Approval details
- PMA number
- P110039
- Trade name
- EXABLATE
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec
- Date received
- 2011-12-05
- Decision date
- 2012-10-18
- Days to decision
- 318 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- General, Plastic Surgery
- Expedited review
- Yes
- Location
- Tirat Carmel
- Statement
- APPROVAL FOR THE EXABLATE SYSTEM, MODEL 2000/2100 /2100 VI. THIS DEVICE IS INDICATED FOR PAIN PALLIATION OF METASTATIC BONE CANCER IN PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE SUFFERING FROM BONE PAIN DUE TO METASTATIC DISEASE AND WHO ARC FAILURES OF STANDARD RADIATION THERAPY, OR NOT CANDIDATES FOR, OR REFUSED RADIATION THERAPY. THE BONE TUMOR TO BE TREATED MUST BE VISIBLE ON NON-CONTRAST MR AND DEVICE ACCESSIBLE.
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