PMA P150038S006
- Device
- ExAblate
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S006
- Product code
- POH
- Decision date
- 2018-12-16
- Classification
- Mr-guided Focused Ultrasound System
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- Approval for the Exablate Model 4000 (Neuro). The device is intended in the unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinson’s Disease with medication-refractory tremor. Patients must be at least age 30.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038S006B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ExAblate
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S006
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2018-12-16
- Decision code
- APPR
- Date received
- 2018-03-07
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Exablate Model 4000 (Neuro). The device is intended in the unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinson’s Disease with medication-refractory tremor. Patients must be at least age 30.