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Blazer II Xp, Blazer Prime Xp & Blazer Xp Rpm Cardiac Ablation Catheters & Sterile Cables

by Boston Scientific

PMA P020025

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P020025↗

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 NumberP020025 Date25 Aug 2003ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0202-2019 FDA Class II initiated 20 Jun 2018

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Trade Name
Ep Technologies Ept-1000 Xp Rf Ablation System
Generic Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
PMA Number
FDA Product Code
OAD
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 XP, Blazer Prime XP, and Blazer XP RPM are percutaneous cardiac ablation catheters designed for the treatment of atrial flutter. These devices are used in electrophysiology procedures to deliver energy to cardiac tissue to address specific heart rhythm conditions.

These catheters are supplied with compatible electrophysiology cables, including models M0046130, M0046510, M0046810, and M004620620. The devices are manufactured by Boston Scientific and have received FDA PMA authorization for clinical use. Users should refer to the specific model documentation for details regarding handling and procedural requirements.

Other devices from Boston Scientific

See all devices from Boston Scientific →

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 are the Blazer II XP and Blazer Prime XP catheters used for?

    These devices are percutaneous cardiac ablation catheters specifically indicated for the treatment of atrial flutter.

  • Are these catheters compatible with specific cables?

    Yes, these catheters are designed to be used with specific electrophysiology cables, such as models M0046130, M0046510, M0046810, and M004620620.

  • Who is the manufacturer of the Blazer XP series?

    The Blazer II XP, Blazer Prime XP, and Blazer XP RPM cardiac ablation catheters are manufactured by Boston Scientific.