FDA.reportPublic FDA data

Evoke® Clarity® Programming Application

Primary DI
09352307002111
Brand
Evoke® Clarity® Programming Application
Company
SALUDA MEDICAL PTY LIMITED
Model
3044
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190002039

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190002039Saluda Medical Evoke SCS SystemSaluda Medical Pty, Ltd.2022-02-28LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09352307002111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352307002111093523070021119352307002111

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation device management softwareA software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.

Regulatory Flags#

DUNS number
744596461
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09352307001756Evoke® CAP24 Paddle Lead Kit30532026-07-06
09352307001787Evoke® CAP24 Paddle Accessory Kit30542026-07-06
09352307001930Evoke® RECAP® Viewer30452026-07-06
09352307000407Evoke® Accessory Belt303930392022-03-15
09352307001800Evoke® RECAP® Viewer30452024-12-13
09352307001909Evoke® Clarity® Programming Application 30442024-12-13
09352307001817Evoke® Active Anchor Kit - L304330432024-03-20
09352307001718Evoke® Active Anchor Kit30432023-10-10
09352307000810Evoke® Active Anchor Kit304330432023-01-04
09352307000131Evoke® Tunnelling Tool301230122022-03-15
09352307001565Evoke® Closed-Loop Stimulator (CLS)30022023-10-10
09352307001572Evoke® Closed-Loop Stimulator (CLS)30422023-10-10
09352307001626Evoke® CAP12 Percutaneous Lead Kit - 60 cm30082023-10-10
09352307001633Evoke® CAP12 Percutaneous Lead Kit - 90 cm30092023-10-10
09352307001640Evoke® CAP12 Percutaneous Lead Kit - 60 cm30082023-10-10
09352307001657Evoke® CAP12 Percutaneous Lead Kit - 90 cm30092023-10-10
09352307001671Evoke® CAP12X Lead Extension Kit - 55 cm30112023-10-10
09352307001695Evoke® Spares Kit 30152023-10-10
09352307001701Evoke® Spares Kit 30152023-10-10
09352307000759Evoke® Closed-Loop Stimulator (CLS)304230422023-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729951124Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729951131Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729951254Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729952046Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953432Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729952053Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953449Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729935070NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935124NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935179NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935186NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729937395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935087Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935094Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729821502NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729950684Entrada ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-04