FDA PMA Number P130022, Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application
FDA PMA Number P130022, Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application
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PMA Number: P130022
Device: Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application
Generic Name: Stimulator, spinal-cord, totally implanted for pain relief
Manufacturer: Nevro Corporation
Product Code: LGW
Date Received: 03/02/2022
Decision Date: 10/12/2022
Notice Date: 01/00/1900
- 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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