FDA.reportPublic FDA data

Evoke® Patient Controller (EPC)

Primary DI
09352307001510
Brand
Evoke® Patient Controller (EPC)
Company
SALUDA MEDICAL PTY LIMITED
Model
3040
Catalog number
3040
Published
2022-10-27
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
P190002010

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190002010Saluda Medical Evoke SCS SystemSaluda Medical Pty, Ltd.2022-02-28LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09352307001510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352307001510093523070015109352307001510

GMDN Terms#

Term, Definition table
TermDefinition
Implantable spinal cord electrical stimulation system programmerA battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
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
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