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FDA PMA Number P040003, EXABLATE
FDA PMA Number P040003, EXABLATE
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Request: FINDINGS OF FOCUS GROUP STUDY BY ALLERGAN RE PMA P020056
Request Year: 2017
PMA Number: P040003
Device: EXABLATE
Generic Name: Ablation system, high intensity focused ultrasound (HIFU), MR-guided
Manufacturer: INSIGHTEC, LTD
Product Code: NRZ
Date Received: 04/07/2015
Decision Date: 10/05/2015
Notice Date: 01/00/1900
Request Year: 2017
PMA Number: P040003
Device: EXABLATE
Generic Name: Ablation system, high intensity focused ultrasound (HIFU), MR-guided
Manufacturer: INSIGHTEC, LTD
Product Code: NRZ
Date Received: 04/07/2015
Decision Date: 10/05/2015
Notice Date: 01/00/1900
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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