ExAblate
FDA premarket approval P150038/S003 · decided 2017-06-26
Approval details
- PMA number
- P150038
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ExAblate
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2017-03-28
- Decision date
- 2017-06-26
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for a software maintenance upgrade from Software Version 6.6 to Version 7.0 for the unilateral Thalamotomy treatment of idiopathic Essential Tremor (ET) patients with medication –refractory tremor.
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