📋 FDA Reference
Endocard Pacing Lead Long Length PL200
Diag
Summary: The Endocard Pacing Lead Long Length PL200 by Diag is a cardiac pacing lead used in cardiac electrophysiology procedures. It is primarily used by cardiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K800349 ↗
Decision Date ?
May 28, 1980
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on May 28, 1980. It is manufactured by Diag and classified as a Class III device under product code DTB.
What It Is
The Endocard Pacing Lead Long Length PL200 is a specialized medical device used for cardiac pacing. It is designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias. The lead is typically inserted into the heart via a vein and positioned in the endocardium, where it can effectively stimulate the heart muscle.
FDA-Cleared Indications
- Cardiac pacing in patients with bradycardia or other rhythm disorders requiring electrical stimulation.
- Transvenous placement of a pacing lead against the heart's endocardial surface.
- Use with a compatible cardiac pacemaker system when pacing support is clinically indicated.
Clinical Applications
- Placement of a transvenous endocardial lead during pacemaker implantation.
- Pacing support for patients with clinically significant slow heart rates.
- Pacing for selected conduction-system disorders when a physician determines that cardiac pacing is needed.
- Use by cardiologists or electrophysiologists in a hospital cardiac electrophysiology setting.
Practical Considerations
- The device is described as a long-length lead; the appropriate length depends on the patient's anatomy and the intended venous access route.
- It is designed for connection to a compatible pacemaker generator; generator and lead compatibility must be confirmed before implantation.
- Placement requires venous access and fluoroscopic or other appropriate imaging guidance, with testing of lead position and electrical performance.
- MRI safety cannot be determined from the available FDA record. The lead should be treated as not established as MRI-conditional unless current manufacturer labeling confirms otherwise.
- Potential contraindications and complications include infection, bleeding, venous or cardiac perforation, lead dislodgement, malfunction, and arrhythmia; patient selection and handling should follow current labeling and institutional protocols.
Frequently Asked Questions
What is the Endocard Pacing Lead Long Length PL200 used for?
It is used for cardiac pacing in patients with arrhythmias, particularly those with bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for patients with heart rhythm disorders that require pacing, such as bradycardia.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.