FDA PMA Number P180046, Axonics Sacral Neuromodulation System

FDA PMA Number P180046, Axonics Sacral Neuromodulation System

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PMA Number: P180046
Device: Axonics Sacral Neuromodulation System
Generic Name: Stimulator, electrical, implantable, for incontinence
Manufacturer: Axonics Modulation Technologies, Inc.
Product Code: EZW
Date Received: 12/06/2018
Decision Date: 11/13/2019
Notice Date: 11/14/2019
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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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