EXABLATE
FDA premarket approval P150038/S002 · decided 2017-04-17
Approval details
- PMA number
- P150038
- Supplement
- S002
- 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
- 2017-01-17
- Decision date
- 2017-04-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for a new Magnetic Resonance (MR) Head Coil for compatibility and use with the 1.5 Tesla (T) MR scanner environment when used with the ExAblate Model 4000 Type 1.0 System.
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