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Blazer II Cardiac Ablation Catheter and Cable

by Boston Scientific

PMA P920047

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

Recall on shared PMA P920047; other models may be affected

Documents

PMA P920047↗

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 NumberP920047 Date28 Oct 1994ApprovedStatusActive

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0202-2019 FDA Class II initiated 20 Jun 2018 on shared PMA P920047

    Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

    • Terminated Z-0973-2011 FDA Unclassified (pre-2012) initiated 14 Jul 2009

    Product malfunction causes inadvertent delivery of energy.

    • Terminated Z-1617-2008 FDA Unclassified (pre-2012) initiated 14 Feb 2008 on shared PMA P920047

    Package sterile barrier may be breached, compromising sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Blazer II TM Cardiac Ablation Catheter and Cable
Trade Name
Ept-1000 Cardiac Ablation System
Generic Name
Cardiac ablation percutaneous catheter
FDA applicant
Boston Scientific Corp
PMA Number
FDA Product Code
LPB
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 Blazer II Cardiac Ablation Catheter and Cable is a Class III percutaneous catheter designed for cardiac ablation procedures. It delivers controlled radiofrequency energy to treat arrhythmias by creating precise lesions in cardiac tissue, restoring normal heart rhythm.

This device is supplied as a reusable system, intended for use in electrophysiology laboratories under sterile conditions. It is regulated under an FDA Premarket Approval (PMA) and includes multiple model variants for compatibility with various ablation systems. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality.

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