Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010326622

FEI Number

3010326622

Entity Name

Centro de Construccion de Cardioestimuladores del Uruguay S.A.

City/State/Country

Montevideo, UY

Establishment Address

General Paz 1363, Montevideo 11400, UY

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GREATBATCH MEDICAL (Owner Number: 9035261)

Owner / Operator Contact Address

2300 Berkshire Lane N, --, Plymouth, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Presidio MedicalTM Spinal Cord Stimulation (SCS) System Vivistim System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SAZ	Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb	Unknown	Class 3	N/A	2025-02-11
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2023-05-15
QPY	Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation	Unknown	Class 3	N/A	2021-11-01
PSR	Implanted Phrenic Nerve Stimulator For Central Sleep Apnea	Unknown	Class 3	N/A	2017-10-23
QFV	Implantable Pulse Generator	Unknown	Class 3	N/A	2019-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Mundaden Email: maria.mundaden@integer.net Phone: (763) 9518200

Related Public Records

Same Entity

GREATBATCH MEDICAL

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011823740	Greatbatch Medical S. de R.L. de C.V.	Tijuana Baja California, MX
3007882731	Greatbatch Medical, S. de R.L. de C.V.	Tijuana Baja California, MX
2183787	Greatbatch Medical	Minneapolis, MN, 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
3026283936	NEUROS MEDICAL INC.	Arden Hills, MN, US
3016618265	Cirtec Medical	Coyol Alajuela, CR
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010326622. Last updated year: 2026. Please use registration number 3010326622 when referencing this establishment in official correspondence.