PMA P110039S003
- Device
- EXABLATE
- Applicant
- Insightec
- PMA number
- P110039
- Supplement
- S003
- Product code
- NRZ
- Decision date
- 2013-08-06
- Classification
- Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- EXABLATE
- Applicant
- Insightec
- PMA number
- P110039
- Supplement
- S003
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2013-08-06
- Decision code
- APPR
- Date received
- 2013-06-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.