Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027063190

FEI Number

3027063190

Entity Name

BIOTRONIK NRO, INC.

City/State/Country

Lake Oswego, OR, US

Establishment Address

6024 Jean Road, Lake Oswego, OR 97035, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Biotronik NRO, INC. (Owner Number: 10087752)

Owner / Operator Contact Address

6024 Jean Road, Lake Oswego, OR 97035, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P210037

All Registered Proprietary Names

Prospera Spinal Cord Stimulation (SCS) System Embrace One HomeStream Remote Management Resilience Percutaneous Lead TrueLock

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	2023-04-04

Official Correspondent

Wee Wen Leow

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biotronik NRO, INC.

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

Similar Registrations

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3020969413	Nevro Medical S.R.L.	El Coyol Alajuela, CR
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 3027063190. Last updated year: 2026. Please use registration number 3027063190 when referencing this establishment in official correspondence.