N'Vision

Basic Information

• Brand Name: N'Vision
• Primary DI: 00763000315443
• Version / Model: 8840
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-13
• Public Version: 1
• Public Version Date: 2020-08-21
• Public Version Status: New
• Public Device Record Key: 8df9e4db-676b-48f7-9ce2-5a028e6b0f88

Device Description

PROG 8840 N'VSION PHYSCN HNDHLD PAPR MAN

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHL	Stimulator, electrical, implanted, for parkinsonian symptoms	Unknown		3
OLM	Deep brain stimulator for obsessive compulsive disorder (OCD)	Unknown		f
MRU	implanted subcortical electrical Stimulator (motor disorders)	Unknown		f
LNQ	intestinal Stimulator	Unknown		f
LKK	Pump, infusion, implanted, programmable	Unknown		3
EZW	Stimulator, electrical, implantable, for incontinence	Gastroenterology, Urology	876.5270	3
MFR	Stimulator, brain, implanted, for behavior modification	Unknown		f
LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	Unknown		3
PJS	Stimulator, electrical, implanted, for essential tremor	Unknown		3
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61393	Multiple active implantable device programmer	An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000315443	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P970004	294

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 135 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -34 – 57 Degrees Celsius