ExAblate (Model 4000) System
FDA premarket approval P150038/S008 · decided 2018-10-24
Approval details
- PMA number
- P150038
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ExAblate (Model 4000) System
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2018-07-23
- Decision date
- 2018-10-24
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval to include the 2-year and 3-year post-market study outcomes in the device labeling.
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