Access® Therapy

Basic Information

• Brand Name: Access® Therapy
• Primary DI: 00613994397836
• Version / Model: 7436
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 4
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: edbc68d1-7f74-4937-a256-d03eff8b411f

Device Description

PROG 7436 KINETRA EZ PATNT ROHs US MKT

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
MFR	Stimulator, brain, implanted, for behavior modification	Unknown		f
MHY	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	Unknown		3
NHL	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS	Unknown		3
OLM	Deep brain stimulator for obsessive compulsive disorder (OCD)	Unknown		f
PJS	Stimulator, electrical, implanted, for essential tremor	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61393	Multiple active implantable device programmer	An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994397836	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H050003	000
P960009	027

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 150 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 65 Degrees Celsius