Exablate Model 4000 Type-1 System
FDA premarket approval P150038/S037 · decided 2025-07-03
Approval details
- PMA number
- P150038
- Supplement
- S037
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Exablate Model 4000 Type-1 System
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2024-07-16
- Decision date
- 2025-07-03
- Days to decision
- 352 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- The Exablate Neuro is intended indicated for use in the unilateral pallidothalamic tractotomy of advanced idiopathic Parkinsons Disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinsons disease medication treatment, and in the staged (by at least 6 months from the first pallidothalamic tractotomy), unilateral pallidothalamic tractotomy of idiopathic Parkinsons Disease with medication-refractory motor complications of their contralateral side that wa
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