Attain Ability™ MRI SureScan™

Basic Information

• Brand Name: Attain Ability™ MRI SureScan™
• Primary DI: 00643169601765
• Version / Model: 419678
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-26
• Public Version: 7
• Public Version Date: 2022-02-02
• Public Version Status: Update
• Public Device Record Key: d5e1fd0b-3740-409a-8edb-c2d6f4025913
• Distribution End Date: 2021-04-15

Device Description

LEAD 419678 MRI CANT US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
DTB	permanent pacemaker Electrode	Cardiovascular	870.3680	3
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60910	Coronary venous pacing lead	An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted cardiac resynchronization therapy (CRT) pulse generator to the left ventricle of the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is introduced into a cardiac vein through transvenous approach via the coronary sinus. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169601765	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080006	085
P080006	147

Device Sizes

Type	Value	Unit	Text
Length	78.0	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 77 – 77 Degrees Fahrenheit