Model 5071 Lead
PMA P120017
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP120017 | Date27 Apr 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Myocardial Pacing Lead
- Trade Name
- Model 5071 Lead
- Generic Name
- permanent pacemaker Electrode
- PMA Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Model 5071 Lead is a permanent pacemaker electrode designed for unipolar ventricular pacing and sensing. It is classified as a permanent pacemaker electrode under the FDA’s nomenclature and is intended for use in permanent ventricular or dual-chamber pacing systems, including bipolar configurations with paired leads.
This lead is supplied sterile and intended for single-use implantation in cardiac patients requiring chronic ventricular or dual-chamber pacing. It is regulated under FDA’s Premarket Approval (PMA) pathway (P120017) and falls under device classification DTB, with a primary application in cardiovascular procedures. Storage and handling must comply with sterile medical device protocols.
Other devices from Medtronic, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of pacing systems can the Model 5071 Lead be used in, and how does it support bipolar configurations?
The Model 5071 Lead is designed for unipolar ventricular pacing and sensing, making it suitable for permanent ventricular or dual-chamber pacing systems. While it is unipolar itself, it can be paired with another compatible lead to create a bipolar pacing configuration, which is often used for improved pacing stability and reduced muscle stimulation.
Is the Model 5071 Lead intended for reuse, or is it meant to be used only once during implantation?
The Model 5071 Lead is explicitly intended for single-use implantation. This ensures sterility and reduces the risk of infection or device degradation from repeated use, aligning with standard sterile medical device protocols.
How should the Model 5071 Lead be stored, and what precautions should be taken during handling?
Since the Model 5071 Lead is supplied sterile, it must be stored and handled according to sterile medical device protocols to maintain its integrity. This includes keeping it in its original packaging until ready for use and avoiding contamination or exposure to environmental hazards.
What regulatory pathway does the Model 5071 Lead follow, and what does this mean for its use in clinical settings?
The Model 5071 Lead is regulated under the FDA’s Premarket Approval (PMA) pathway (PMA P120017), which means it has undergone rigorous review to ensure safety and effectiveness for its intended use in permanent ventricular or dual-chamber pacing systems. This pathway is typically reserved for higher-risk devices, ensuring clinical confidence in its performance.
Can the Model 5071 Lead be used in both ventricular and dual-chamber pacing systems, and how does it differ in those applications?
Yes, the Model 5071 Lead is approved for use in both permanent ventricular pacing systems and dual-chamber pacing systems. In ventricular pacing, it provides unipolar stimulation and sensing of the ventricle, while in dual-chamber systems, it pairs with an atrial lead to coordinate pacing between the atrium and ventricle, improving overall cardiac rhythm management.