EXABLATE
FDA premarket approval P150038 · decided 2016-07-11
Approval details
- PMA number
- P150038
- Trade name
- EXABLATE
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2015-10-21
- Decision date
- 2016-07-11
- Days to decision
- 264 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for the ExAblate Model 4000 Type 1.0 System (ExAblate Neuro). This device is indicated for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the ExAblate device.
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