ExAblate
FDA premarket approval P150038/S006 · decided 2018-12-16
Approval details
- PMA number
- P150038
- Supplement
- S006
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ExAblate
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2018-03-07
- Decision date
- 2018-12-16
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for the Exablate Model 4000 (Neuro). The device is intended in the unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinsons Disease with medication-refractory tremor. Patients must be at least age 30.
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