PMA P150038S010
- Device
- Exablate 4000 (“Neuro”) Type 1.0 & 1.1
- Applicant
- Insightec
- Product code
- POH
- Decision date
- 2020-11-09
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Approval of the revised protocol, Protocol Number PD012 – Version 1, amended on April 28, 2020, for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Exablate 4000 (“Neuro”) Type 1.0 & 1.1
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S010
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2020-11-09
- Decision code
- APPR
- Date received
- 2019-02-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol, Protocol Number PD012 – Version 1, amended on April 28, 2020, for the post-approval study (PAS) protocol.