Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021836309

FEI Number

3021836309

Entity Name

Saluda Medical Pty. Ltd.

City/State/Country

Macquarie Park New South Wales, AU

Establishment Address

5 Eden Park Drive, Macquarie Park New South Wales 2113, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Saluda Medical Pty Ltd (Owner Number: 10061701)

Owner / Operator Contact Address

5 Eden Park Drive, Macquarie Park, AU-NSW 2113, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Evoke(R) Lead Adapter Kit Evoke(R) 12C Percutaneous Trial Lead Kit Evoke(R) Accessory Belt Evoke(R) eCLS Case Evoke(R) Charger Evoke(R) External Closed-Loop Stimulator Evoke(R) 12C Percutaneous Lead Kit Evoke(R) Patient Controller Evoke(R) Intraoperative Cable Kit Evoke(R) Epidural Needle Evoke(R) 12C Lead Extension Kit Evoke(R) eCLS Battery Charger Kit Evoke(R) Clinical Interface Evoke(R) Closed-Loop Stimulator Evoke(R) Tunneling Tool Evoke(R) Clinical System Transceiver Evoke Epidural Needle, 6.5" Evoke 12C Percutaneous Lead Kit - 90cm Evoke Tunneling Tool Evoke 12C Percutaneous Lead Kit - 60cm Evoke Intraoperative Cable Kit Evoke Spares Kit Evoke 12C Lead Extension Kit - 55cm Evoke Lead Adapter Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2022-03-09
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2022-03-09
EZW	Stimulator, Electrical, Implantable, For Incontinence	Gastroenterology, Urology	Class 3	876.5270	2022-10-25
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2019-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

John Daley Business: Saluda Medical Pty Ltd Email: john.daley@saludamedical.com Phone: (508) 2595100

Related Public Records

Same Entity

Saluda Medical Pty Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

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3008514029	NEVRO CORP.	Redwood City, CA, US
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
2182207	MEDTRONIC NEUROMODULATION	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021836309. Last updated year: 2026. Please use registration number 3021836309 when referencing this establishment in official correspondence.