INTERSTIM®

Basic Information

• Brand Name: INTERSTIM®
• Primary DI: 00613994925947
• Version / Model: 305901
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-25
• Public Version: 4
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: a0b06583-be4f-41cb-bb04-a344ff98cad8
• Distribution End Date: 2022-10-25

Device Description

LEAD 305901 PNE TEST STIM LEAD EMAN

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: No
• Has Lot/Batch Number: Yes
• 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
61394	Sacral plexus percutaneous incontinence-control electrical stimulation system electrode	A sterile wire, insulated with non-conductive material except at its electrode(s), intended to be percutaneously introduced short-term (<=30 days) to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence, by making to make an electrical connection between an external electrical stimulation system pulse generator and the sacral plexus. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994925947	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080025	083
P970004	187

Storage Conditions

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