FDA.reportPublic FDA data

Evoke® Clinical Interface (CI)

Primary DI
09352307001183
Brand
Evoke® Clinical Interface (CI)
Company
SALUDA MEDICAL PTY LIMITED
Model
3024
Catalog number
3024
Published
2022-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
P190002011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190002011Saluda Medical Evoke SCS SystemSaluda Medical Pty, Ltd.2022-02-28LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09352307001183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352307001183093523070011839352307001183

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation device management softwareA software program intended to assist with the management of an implantable electrical stimulation device. 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-implant visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744596461
Device count
1
Serial number
true
Manufacturing date on label
true

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
09352307002111Evoke® Clarity® Programming Application30442026-07-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729970606Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-01-16
08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
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
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
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