CapSure Sense®

Basic Information

• Brand Name: CapSure Sense®
• Primary DI: 00643169590502
• Version / Model: 407445
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-14
• Public Version: 6
• Public Version Date: 2024-03-20
• Public Version Status: Update
• Public Device Record Key: 0ba5c7d5-3350-4ce4-83f2-6aac09d4c12e
• Distribution End Date: 2018-10-10

Device Description

LEAD 407445 CAPSURE SENSE US BI RCMCRD

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTB	permanent pacemaker Electrode	Cardiovascular	870.3680	3
NVY	Permanent defibrillator electrodes	Unknown		3
NVN	Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35223	Endocardial/interventricular septal pacing lead	An implantable 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 pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169590502	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P830061	113

Device Sizes

Type	Value	Unit	Text
Length	45.0	Centimeter

Storage Conditions

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