FDA.reportPublic FDA data

Evoke® Clarity® Programming Application

Primary DI
09352307001909
Brand
Evoke® Clarity® Programming Application
Company
SALUDA MEDICAL PTY LIMITED
Model
3044
Published
2024-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190002017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190002017Saluda Medical Evoke SCS SystemSaluda Medical Pty, Ltd.2022-02-28LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09352307001909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352307001909093523070019099352307001909

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744596461
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09352307000407Evoke® Accessory Belt303930392022-03-15
09352307001800Evoke® RECAP® Viewer30452024-12-13
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
09352307000773Evoke® CAP12 Percutaneous Lead Kit - 60 cm300830082023-01-04
09352307000780Evoke® CAP12 Percutaneous Lead Kit - 90 cm300930092023-01-04
09352307000797Evoke® CAP12 Trial Percutaneous Lead Kit - 60 cm301630162023-01-04
09352307000803Evoke® CAP12 Trial Percutaneous Lead Kit - 90 cm301730172023-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
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08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
08714729935070NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
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08714729931492NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-05-03
08714729763352Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-02-23
08714729789697Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729789703Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729767534Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767541Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767558Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729779957NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729779964NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789567Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789581Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797807Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797814Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797821Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797838NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729821540NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767640Precision ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-11-09
08714729772699NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-11-09
08714729791973Clik™ AnchorBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-11-09