INSIGHTEC EXABLATE SYSTEM
FDA premarket approval P110039/S001 · decided 2013-03-15
Approval details
- PMA number
- P110039
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- INSIGHTEC EXABLATE SYSTEM
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec
- Date received
- 2012-11-06
- Decision date
- 2013-03-15
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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