Select Secure Lead Model 3830
by Medtronic Cardiac Rhythm Disease Management PMA
Active
PMA P030036
Overview
The Select Secure Lead Model 3830 is a drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrode designed for use in implantable atrial or ventricular, single-chamber or dual-chamber pacemaker systems. It is intended for pacing and sensing in the atrium or ventricle.
This device is supplied as part of a pacemaker system and is intended for permanent implantation. The Model 3830 lead has received FDA PMA approval for use in indicated pacemaker systems. It is available in various sizes and configurations as specified by the manufacturer.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP030036 | Date3 Aug 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Select Secure Lead
- Trade Name
- Medtronic Selectsecure Lead Model 3830
- Generic Name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- PMA Number
- FDA Product Code
- NVN
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
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Questions
What is the Select Secure Lead Model 3830 used for?
The Select Secure Lead Model 3830 is a drug eluting permanent pacemaker electrode designed for pacing and sensing in either the right ventricle or right atrium of patients with single-chamber or dual-chamber pacemaker systems.
How is the Select Secure Lead Model 3830 supplied?
The device is supplied as part of a pacemaker system and is intended for permanent implantation. It is available in various sizes and configurations as specified by the manufacturer.
Is the Select Secure Lead Model 3830 single-use or reusable?
The Select Secure Lead Model 3830 is designed for permanent implantation and is not intended to be reused.
What regulatory approval does the Select Secure Lead Model 3830 have?
The Select Secure Lead Model 3830 has received FDA PMA approval for use in indicated pacemaker systems.