INTERSTIM® II

Basic Information

• Brand Name: INTERSTIM® II
• Primary DI: 00643169974760
• Version / Model: 3058
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-24
• Public Version: 2
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: 837a5598-7ceb-406d-9721-9a8ef5ae2b1a
• Distribution End Date: 2022-10-25

Device Description

INS 3058 INTERSTIM II EMAN US GRC

Device Characteristics

• Single Use: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZW	Stimulator, electrical, implantable, for incontinence	Gastroenterology, Urology	876.5270	3
QON	Implanted electrical device intended for treatment of fecal incontinence	Gastroenterology, Urology	876.5270	3

GMDN Terms

Code	Name	Definition	Implantable	Status
61391	Implantable incontinence-control electrical stimulation system pulse generator	A sterile, hermetically-sealed, battery-powered component of an implantable incontinence-control pelvic electrical stimulation system, intended to be implanted beneath the skin (e.g., upper buttock area) to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via implantable electrodes (not included), and the pulse generator may be controlled by an external programmer.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169974760	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080025	154
P970004	259

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 52 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 125 Degrees Fahrenheit