SureFix Model 5072 Pacing Lead
PMA P930039
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP930039 | Date12 Aug 1998 | 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- Withdrawn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
- Capsure Pacing Lead
- Trade Name
- Surefix Tm Model 5072 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
- PMA Supplement
- S006
Overview
AI-generated summary, 18 Sep 2026
The SureFix Model 5072 Pacing Lead is a permanent pacemaker electrode, designed for implantation in the cardiovascular system. It delivers electrical stimulation to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders, ensuring consistent pacing support for sustained cardiac function.
This lead is intended for single-use implantation in cardiac electrophysiology procedures, supplied sterile and packaged for surgical use. It is classified as a Class III device under FDA regulations and requires a Premarket Approval (PMA) for distribution. The lead is compatible with standard pacemaker systems and adheres to MRI safety guidelines for non-ferromagnetic components, with specific model and reference codes ensuring traceability and regulatory compliance.
Other devices from Medtronic, Inc.
Questions
AI-generated answers, 18 Sep 2026
Is the SureFix Model 5072 Pacing Lead intended for reuse in multiple patients or is it designed for single-use only?
The SureFix Model 5072 Pacing Lead is explicitly designed for **single-use implantation** in cardiac electrophysiology procedures. It is supplied sterile and packaged for surgical use, ensuring it meets regulatory standards for one-time patient application only.
What types of pacemaker systems is this lead compatible with, and how does it ensure safety during MRI procedures?
The SureFix Model 5072 Pacing Lead is **compatible with standard pacemaker systems** as part of its intended use for regulating heart rhythm. It adheres to **MRI safety guidelines** by incorporating **non-ferromagnetic components**, reducing risks associated with magnetic resonance imaging. Specific model and reference codes also support traceability and regulatory compliance.
How is this lead supplied, and what should clinicians consider regarding sterility and handling before implantation?
The lead is supplied **sterile and pre-packaged for surgical use**, ensuring it is ready for immediate implantation without additional sterilization. Clinicians should handle it with sterile techniques, as it is intended for **single-use only**, and must follow manufacturer guidelines to maintain sterility until deployment.
What regulatory pathway was followed for this device, and what does that mean for its distribution?
The SureFix Model 5072 Pacing Lead requires **Premarket Approval (PMA)** under FDA regulations, as it is classified as a **Class III device**. This means its distribution is governed by the **PMA approval process**, including compliance with manufacturing site requirements (e.g., Medtronic Puerto Rico, Inc.). The PMA number **P930039** and associated supplements (e.g., **S006**) ensure traceability and adherence to regulatory standards.