NA

Basic Information

• Brand Name: NA
• Primary DI: 00613994972286
• Version / Model: 37022
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 5
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 07cc2eff-3f1c-459c-a690-d5c1b8c84df8

Device Description

PRGM 37022 ENS ULTRA/ACTIVA FLEX

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
MHY	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	Unknown		3
MFR	Stimulator, brain, implanted, for behavior modification	Unknown		f
LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	Unknown		3
MRU	implanted subcortical electrical Stimulator (motor disorders)	Unknown		f
OLM	Deep brain stimulator for obsessive compulsive disorder (OCD)	Unknown		f
MBX	STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED	Unknown		3
PJS	Stimulator, electrical, implanted, for essential tremor	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61472	Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator	An electrically-powered, external component of a spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system intended to be used during a trial period (<= 30 days) to test operating parameters prior to implantation of the permanent system. It produces electrical impulses intended to relieve acute and/or chronic intractable pain (analgesia) via percutaneous electrodes (not included) placed in the epidural space of the spinal cord or in/near a peripheral nerve(s) (e.g., lumbar, truncal, in a limb).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994972286	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H020007	051
H050003	021
P840001	176
P960009	107
P960009	219

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 149 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -40 – 65 Degrees Celsius