Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016618265

FEI Number

3016618265

Entity Name

Cirtec Medical

City/State/Country

Coyol Alajuela, CR

Establishment Address

Edificio B11, Zona Franca Coyol, Coyol Alajuela N/A, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cirtec Medical Corporation (Owner Number: 10025422)

Owner / Operator Contact Address

9200 Xylon Ave N, Brooklyn Park, MN 55445, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stimulator, spinal-cord, totally implanted for pain relief

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	2024-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Schnabel Business: Cirtec Medical Corporation Email: michael.schnabel@cirtecmed.com Phone: (763) 2358703

Related Public Records

Same Entity

Cirtec Medical Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013368220	CIRTEC MEDICAL	Brooklyn Park, MN, US
3004737415	Cirtec Medical	Santa Clara, CA, US
3024996452	CIRTEC MEDICAL	Brooklyn Park, MN, US
3009183442	Cirtec Medical	Enfield, CT, US

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

Registration Number	Establishment Name	Location
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
3021836309	Saluda Medical Pty. Ltd.	Macquarie Park New South Wales, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016618265. Last updated year: 2026. Please use registration number 3016618265 when referencing this establishment in official correspondence.