N'VISION 8840

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: N'VISION™ FDA UDI
Generic Name: Multiple active implantable device programmer FDA UDI
Device Name: PRGMR 8840 N'VISION PHYSICIAN HANDHELD FDA UDI
Model / Reference: 8840 FDA UDI
Description: PRGMR 8840 N'VISION PHYSICIAN HANDHELD FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994997838 FDA UDI
PMA Number: P080025 FDA UDI
P840001 FDA UDI
P860004 FDA UDI
P960009 FDA UDI
P970004 FDA UDI
FDA Product Code: NHL FDA UDI
LGW FDA UDI
MHY FDA UDI
EZW FDA UDI
MFR FDA UDI
LKK FDA UDI
MRU FDA UDI
LNQ FDA UDI
OLM FDA UDI
QRB FDA UDI
QON FDA UDI
PJS FDA UDI
GMDN Term: Multiple active implantable device programmer FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 876.5270 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple active implantable device programmer

The N'VISION 8840 is a multiple active implantable device programmer, defined as an external, portable, non-dedicated, electrically-powered device intended to change, noninvasively and wirelessly, the operating parameters of multiple types of implanted electronic devices, such as pulse generators. It includes controls, integrated software, and a wireless communication transmitter and receiver, and typically provides historic and/or current information regarding the performance of the implant.

This physician handheld device is used in clinical settings to program implanted electronic devices and external trial devices. It is supplied as a reusable, non-sterile, prescription-only unit with no MRI safety information provided. Storage conditions require handling environment temperatures between -40°C and 65°C (-40°F to 149°F) and relative humidity between 30% and 75%. The device is in commercial distribution and is associated with product codes for various implanted stimulators, including those for Parkinsonian symptoms, spinal-cord pain relief, incontinence, and behavior modification.

Similar devices

Also classified as Multiple active implantable device programmer.

Wearable Antenna Assembly/StimQ Wearable Antenna Gear — STIMWAVE TECHNOLOGIES INCORPORATED · Class II
HeartMate Touch™ — Thoratec Corp · Class III
SJM™ — ST. JUDE MEDICAL, INC. · Class III
Genesis™ — ST. JUDE MEDICAL, INC. · Class III
SeaSilk Antenna Large 28" Length — STIMWAVE TECHNOLOGIES INCORPORATED · Class II
SJM MRI Activator™ — ST. JUDE MEDICAL, INC. · Class III
Large Antenna 30" Length — STIMWAVE TECHNOLOGIES INCORPORATED · Class II
Merlin™ — ST. JUDE MEDICAL, INC. · Class III

Cleared under the same submission

P080025 also covers:

P840001 also covers:

P860004 also covers:

P960009 also covers:

P970004 also covers:

Frequently asked questions

What types of implants can the N'VISION 8840 program?

It is designed to program multiple types of implanted electronic devices, including pulse generators for Parkinsonian symptoms, spinal-cord pain relief, incontinence, behavior modification, and infusion pumps. It also supports external trial devices used prior to implantation.

Is the N'VISION 8840 supplied sterile or for single use?

No, it is supplied as a reusable, non-sterile unit. It is not sterilized prior to use and is not intended for single-patient application.

What are the storage and handling requirements for this device?

It must be stored in an environment with temperatures between -40°C and 65°C (-40°F to 149°F) and relative humidity between 30% and 75%. These conditions ensure the device remains functional during storage and transport.

Does the N'VISION 8840 have MRI safety information?

No, the labeling for this device does not contain any MRI safety information. Users should consult additional documentation or contact the manufacturer for guidance on MRI compatibility if needed.

Is a prescription required to obtain the N'VISION 8840?

Yes, it is a prescription-only device, meaning it must be ordered and used under the supervision of a qualified healthcare professional.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI d96fa5ca-de71-43e7-9829-3892a6f27f52 36 fields · synced Sep 26, 2026