FDA.reportPublic FDA data

Axonics

Primary DI
10810005340035
Brand
Axonics
Company
AXONICS MODULATION TECHNOLOGIES, INC.
Model
2501
Catalog number
2501
Device description
Clinician Programmer
Published
2019-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZWStimulator, Electrical, Implantable, For Incontinence
QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3
QONImplanted Electrical Device Intended For Treatment Of Fecal IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190006000Axonics Sacral Neuromodulation SystemBoston Scientific Corporation2019-09-06QON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810005340035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081000534003510810005340035

GMDN Terms#

Term, Definition table
TermDefinition
Implantable incontinence-control electrical stimulation system programmer, line-poweredA line-powered, external device intended to change, noninvasively, one or more of the operating parameters (the programs) of an implanted incontinence-control electrical stimulation system pulse generator. It is designed to read stored parameters in the implanted device, providing historic and/or current information regarding device performance. The device is typically an electronic wand with a communication antenna that connects to the port of a personal computer (PC) with dedicated software. The PC drives the electronics of the wand to communicate with the implanted stimulation system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (877) 929-6642customersupport@axonics.com

Regulatory Flags#

DUNS number
079562449
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810005340424Axonics9108-R2020-11-03
10810005340431Axonics9108-E2020-11-03
10810005340233Axonics900590052019-09-23
10810005340264Axonics9008-R9008-R2019-09-23
10810005340271Axonics9008-E9008-E2019-09-23
10810005340011Axonics140114012019-09-23
10810005340370Axonics140114012019-09-23
10810005340387Axonics140114012019-09-23
10810005340479Axonics510151012023-09-08
10810005340455Axonics410141012022-03-11
10810005340066Axonics110111012019-09-23
10810005340523AxonicsFFG-01FFG-012025-02-05
10810005340509Bulkamid500502023-09-12
10810005340578Axonics900990092024-07-29
10810005340493Bulkamid600302023-08-30
10810005340486Axonics901590152022-06-14
10810005340059Axonics160116012019-09-23
10810005340080Axonics180118012019-09-23
10810005340103Axonics230123012019-09-23
10810005340127Axonics190119012019-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150005918NAMEDTRONIC, INC.QON2026-03-27
00199150005918NAMEDTRONIC, INC.EZW2026-03-27
00199150005925NAMEDTRONIC, INC.QON2026-03-27
00199150005925NAMEDTRONIC, INC.EZW2026-03-27
10810005340523AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2025-02-05
10810005340578AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2024-07-29
00763000596835InterStim™SureScan™MEDTRONIC, INC.QON2024-01-22
00763000596873InterStim™SureScan™MEDTRONIC, INC.EZW2024-01-22
00763000612832N/AMEDTRONIC, INC.QON2024-01-19
00763000612832N/AMEDTRONIC, INC.EZW2024-01-19
00763000596798InterStim™SureScan™MEDTRONIC, INC.QON2023-12-15
00763000596910InterStim™SureScan™MEDTRONIC, INC.QON2023-12-15
10810005340479AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2023-09-08
00763000825997NAMEDTRONIC, INC.EZW2023-04-07
00763000596996InterStim™SureScan™MEDTRONIC, INC.QON2023-01-23
00763000596958InterStim™SureScan™MEDTRONIC, INC.EZW2023-01-01
10810005340486AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2022-06-14
00763000596736InterStim™ Micro SureScan™ MRIMEDTRONIC, INC.EZW2022-06-05
10810005340455AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2022-03-11
00763000484668InterStim™ XMEDTRONIC, INC.EZW2022-03-04
00763000517182NAMEDTRONIC, INC.QON2022-03-04
00763000517199NAMEDTRONIC, INC.QON2022-03-04
00763000582470NAMEDTRONIC, INC.QON2022-03-04
00763000582487NAMEDTRONIC, INC.EZW2022-03-04
00763000449711INTERSTIM® IIMEDTRONIC, INC.EZW2021-05-30
00763000433864N/AMEDTRONIC, INC.QON2021-05-21
00763000433871N/AMEDTRONIC, INC.QON2021-05-21
00763000343286NAMEDTRONIC, INC.QON2021-02-15
00763000295523InterStim™MEDTRONIC, INC.QON2021-01-25
00763000295547InterStim™MEDTRONIC, INC.QON2021-01-25