Exablate 4000 System Type-1 (i.e. Type 1.0/1.1)
FDA premarket approval P150038/S022 · decided 2022-12-08
Approval details
- PMA number
- P150038
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Exablate 4000 System Type-1 (i.e. Type 1.0/1.1)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2022-06-14
- Decision date
- 2022-12-08
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for labeling changes to the indications for use of the device in idiopathic Essential tremor patients with medication-refractory tremor.
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