Exablate Model 4000 System
FDA premarket approval P150038/S009 · decided 2019-06-28
Approval details
- PMA number
- P150038
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Exablate Model 4000 System
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2018-12-17
- Decision date
- 2019-06-28
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for the Exablate 4000 Type 1.1 System SW Version 7.3 to support the operation of the Type 1.1 System SW version 7.2 and to include compatibility with the GE Premier Magnetic Resonance (MR) System.
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