FDA.reportPublic FDA data

AXONICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30029686853002968685AXONICS, INC.1Y2026-01-0115515 Sand Canyon Ave Irvine CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3347471888768123P190006Axonics Sacral Neuromodulation SystemQON2019-09-06
3347471332365242P180046Axonics Sacral Neuromodulation SystemEZW2019-11-13
3347471712452773P170023Bulkamid Urethral Bulking SystemLNM2020-01-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EZW22019-11-13
LNM 12020-01-28

PMN#