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Myopore Sutureless Myocardial Pacing Lead

by Great Batch Medical

PMA P130012

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 P130012↗

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 NumberP130012 Date30 Apr 2015ApprovedStatusActive

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  • Withdrawn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

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

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

The Myopore Sutureless Myocardial Pacing Lead is a permanent pacemaker electrode designed for ventricular epicardial attachment when transvenous leads are unsuitable or when dislodgement risk must be minimised. It is intended for use in situations where pacing and/or sensing must be established following open-heart surgery, providing secure fixation without sutures.

This device is supplied sterile and intended for single-use in cardiac surgical settings. It is classified as a Class III medical device under FDA regulations (870.3680) and requires FDA_PMA authorisation. The lead is available in multiple reference codes (e.g., 3002618605, 1028232) and must be handled and stored according to manufacturer instructions to maintain sterility and functionality.

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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 Myopore Sutureless Myocardial Pacing Lead used for?

    The Myopore Sutureless Myocardial Pacing Lead is designed for ventricular epicardial attachment when transvenous leads are unsuitable or when dislodgement risk must be minimized. It is used to establish pacing and/or sensing following open-heart surgery.

  • Is the Myopore lead reusable or single-use?

    The Myopore Sutureless Myocardial Pacing Lead is supplied sterile and intended for single-use in cardiac surgical settings to ensure safety and functionality.

  • How should the Myopore lead be stored?

    The lead must be handled and stored according to manufacturer instructions to maintain sterility and functionality, though specific storage conditions are not detailed in the provided data.

  • What regulatory authorization does the Myopore lead have?

    The Myopore Sutureless Myocardial Pacing Lead has FDA_PMA authorization, indicating it received Premarket Approval from the FDA as a Class III medical device.