EXABLATE NEURO THALAMOTOMY
FDA premarket approval P150038/S001 · decided 2016-09-29
Approval details
- PMA number
- P150038
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EXABLATE NEURO THALAMOTOMY
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2016-08-03
- Decision date
- 2016-09-29
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval of the protocol for the ODE Lead PMA Post-Approval Study protocol.
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