Exablate
FDA premarket approval P150038/S034 · decided 2024-02-27
Approval details
- PMA number
- P150038
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Exablate
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2024-01-29
- Decision date
- 2024-02-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- a change of the manufacturing method for the head membrane rings from computer numerical control (CNC) machining to molding, and the manufacturing method of attaching the rings to head membrane was changed from screws to over-molding
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