Exablate 4000 (Neuro) Type 1.0 & 1.1
FDA premarket approval P150038/S010 · decided 2020-11-09
Approval details
- PMA number
- P150038
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Exablate 4000 (Neuro) Type 1.0 & 1.1
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2019-02-01
- Decision date
- 2020-11-09
- Days to decision
- 647 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval of the revised protocol, Protocol Number PD012 Version 1, amended on April 28, 2020, for the post-approval study (PAS) protocol.
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