Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Premarket Approval P180046

Pre-market Approval Supplement Details

Approval for the axonics sacral neuromodulation system. The device is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

DeviceAxonics Sacral Neuromodulation System
Classification NameStimulator, Electrical, Implantable, For Incontinence
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantAxonics Modulation Technologies, Inc.
Date Received2018-12-06
Decision Date2019-11-13
Notice Date2019-11-14
PMAP180046
SupplementS
Product CodeEZW
Docket Number19M-5393
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address Axonics Modulation Technologies, Inc. 26 Technology Drive irvine, CA 92618
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P180046Original Filing

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