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Capsure Epicardial Pacing Lead

by Medtronic, Inc.

PMA P950024

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P950024↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP950024 Date6 Sep 1996ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Medtronic(R) Capsure(R) Epi Pacing Lead Model 4695
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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Capture Epicardial Pacing Lead Model 4965 is a drug-eluting permanent pacing electrode designed for epicardial implantation. It is classified as a drug-eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrode, intended for use in cardiac pacing applications requiring reliable electrical conduction and tissue integration over time.

This lead is supplied sterile and intended for single-use implantation during surgical procedures. It is regulated under FDA Premarket Approval (PMA) with approval number P950024, adhering to Class III medical device standards. Storage and handling must comply with sterile medical device protocols to ensure functionality and safety prior to use.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Medtronic Capture Epicardial Pacing Lead Model 4965, and where is it typically implanted?

    The Medtronic Capture Epicardial Pacing Lead Model 4965 is designed for epicardial implantation and is intended for cardiac pacing applications. It provides reliable electrical conduction and tissue integration over time, making it suitable for permanent pacing in the right ventricle (RV) or right atrium (RA). This lead is specifically engineered for surgical implantation on the outer surface of the heart.

  • Is the Medtronic Capture Epicardial Pacing Lead Model 4965 intended for single-use or reusable applications, and how should it be stored?

    The Medtronic Capture Epicardial Pacing Lead Model 4965 is intended for single-use implantation during surgical procedures. Since it is supplied sterile, storage and handling must adhere to strict sterile medical device protocols to maintain its functionality and safety prior to use. Always follow manufacturer guidelines for proper storage conditions.

  • What regulatory pathway does the Medtronic Capture Epicardial Pacing Lead Model 4965 follow, and when was it approved?

    The Medtronic Capture Epicardial Pacing Lead Model 4965 is regulated under the FDA Premarket Approval (PMA) pathway, classified as a Class III medical device. It received approval under PMA number P950024 on September 6, 1996, following a review by the FDA’s Cardiovascular advisory committee.

  • Does the Medtronic Capture Epicardial Pacing Lead Model 4965 have any special features, such as drug elution, that enhance its performance?

    Yes, the Medtronic Capture Epicardial Pacing Lead Model 4965 is a drug-eluting permanent pacing electrode. This feature helps promote reliable electrical conduction and supports tissue integration over time, improving long-term performance in cardiac pacing applications.