Endocardial Carbon-Tip Lead
by Pacesetter Systems 510(k)PMA
Active
PMA P800041510(k) K861481
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK861481 | Date6 Jun 1986 | StatusActive |
| United States | FDA PMA PMA | NumberP800041 | Date27 Jan 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k), FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Endocardial Pacemaker Lead W/Carbon Tip
- Generic Name
- permanent pacemaker Electrode
- PMA Number
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
- PMA Supplement
- S002
Overview
AI-generated summary, 18 Sep 2026
The Endocardial Carbon-Tip Lead is a permanent pacemaker electrode manufactured by Pacesetter Systems. It is designed to function as an endocardial lead, facilitating the transmission of electrical impulses between a pacemaker and the heart tissue.
This device is classified as a Class 3 medical device under regulation number 870.3680. It has received both FDA 510(k) clearance and PMA authorization for use in cardiovascular procedures.
Other devices from Pacesetter Systems
Questions
AI-generated answers, 18 Sep 2026
What is the primary function of the Endocardial Carbon-Tip Lead?
This device serves as a permanent pacemaker electrode, which is used to deliver electrical stimulation from a pacemaker to the heart to regulate cardiac rhythm.
Who is the manufacturer of this pacemaker lead?
The Endocardial Carbon-Tip Lead is manufactured by Pacesetter Systems, based in Sylmar, California.
Is this device regulated by the FDA?
Yes, the device is authorized under FDA 510(k) and PMA regulatory pathways, and it is classified as a Class 3 medical device.