Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro)
FDA premarket approval P150038/S014 · decided 2021-10-29
Approval details
- PMA number
- P150038
- Supplement
- S014
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2021-03-31
- Decision date
- 2021-10-29
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for the Exablate Neuro. The device is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic Parkinsons disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinsons disease medication treatment. Patients must be at least age 30. The designated area in the brain responsible for the movement disorder symptoms [globus pallidus (GPi)] must be identified and accessible for targeted thermal ablation by the Exablate device
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