N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00643169834330
• Version / Model: A521
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-14
• Public Version: 5
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: b64a4cea-9022-4fc6-b9cf-3f1697e44197

Device Description

SW APP A521 GU PATIENT EVALUATION

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: No
• Has Lot/Batch Number: Yes
• 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
EZW	Stimulator, electrical, implantable, for incontinence	Gastroenterology, Urology	876.5270	3

GMDN Terms

Code	Name	Definition	Implantable	Status
61395	Wearable peripheral nerve electrical stimulator programmer	A portable, electrically-powered external device intended to wirelessly change one or more of the operating parameters (the programs) of a wearable peripheral nerve electrical stimulation system pulse generator. It may be a digital device which includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver, or it may contain magnets of different field strengths that transmit commands when proximal to the stimulator. It is typically used during a trial period (<30 days) to validate the therapy. It is intended for use by both a clinician and a patient/layperson (under the guidance of a clinician) in a home or a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169834330	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080025	142
P080025	197
P970004	247
P970004	302