NA

Basic Information

• Brand Name: NA
• Primary DI: 00643169974784
• Version / Model: 3537FA
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-11
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: c41595a8-a8d9-4f1e-89cf-fd5427a11108

Device Description

PROG 3537FA PAT ISTM TESTSTM CONT FA GRC

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
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	00643169974784	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080025	152
P970004	257

Storage Conditions

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