BIOTRONIK

Basic Information

• Brand Name: BIOTRONIK
• Primary DI: 04035479170127
• Version / Model: Prospera EPG
• Catalog Number: 457861
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-06
• Public Version: 1
• Public Version Date: 2023-04-14
• Public Version Status: New
• Public Device Record Key: e5341d99-8ce9-4851-80e8-f808e296eb2d

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
LGW	Stimulator, spinal-cord, totally implanted for pain relief	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	04035479170127	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P210037	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 113 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal