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Paradym CRT-D; Paradym RF CRT-D (ZL101), (ZL102); Intensia CRT-D; Platinium CRT-D 1711, 1741.

by MicroPort CRM USA, Inc.

PMA P060027

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P060027↗

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 NumberP060027 Date15 May 2008ApprovedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-3230-2017 FDA Class II initiated 24 Jul 2017
    • Terminated Z-3233-2017 FDA Class II initiated 24 Jul 2017

    There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

    • Terminated Z-2579-2010 FDA Unclassified (pre-2012) initiated 7 Jun 2010

    The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occurs under a specific sequence of events.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Trade Name
Ovatio Crt System
Generic Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
FDA applicant
MicroPort CRM S.r.l.
PMA Number
FDA Product Code
NIK
Models / Variants
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 Ovatio CRT-D System is an Automatic Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D). It is designed to deliver ventricular antitachycardia pacing and defibrillation for automated treatment of life-threatening arrhythmias while synchronizing cardiac contractions to improve heart function in patients with severe heart failure. The device incorporates a left ventricular lead (Situs OTW LV Lead) positioned via a coronary vein to enable biventricular pacing, targeting patients with reduced ejection fraction and prolonged QRS duration.

The system is intended for use in conjunction with ELA Medical cardiac synchronization therapy pulse generators and is supplied as a sterile, implantable device. It is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA). Models include the ZL101, ZL102, Intensia CRT-D, and Platinium CRT-D variants (1711, 1741), each with distinct lead configurations and pulse generator compatibility. Storage and handling follow sterile medical device protocols, and regulatory compliance is ensured through FDA-authorized PMA (P060027).

Other devices from MicroPort CRM USA, Inc.

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 specific patient population is the Ovatio CRT-D System designed to treat, and what clinical criteria are considered for its use?

    The Ovatio CRT-D System is designed for patients with severe heart failure who are medically optimized and fall into NYHA functional class III or IV. It is indicated for those with a left ventricular ejection fraction of 35% or less and a QRS duration of 150 milliseconds or longer. The system’s left ventricular lead (Situs OTW LV Lead) is positioned via a coronary vein to enable biventricular pacing, targeting synchronized cardiac contractions to improve heart function and reduce symptoms.

  • How is the Ovatio CRT-D System supplied, and what considerations should be taken into account during storage and handling?

    The Ovatio CRT-D System is supplied as a sterile, implantable device, adhering to standard sterile medical device protocols. Since it is a Class III device, proper sterile packaging and handling are critical to maintain integrity before implantation. Storage should follow manufacturer guidelines to preserve sterility and functionality, ensuring compliance with regulatory requirements for implantable cardiac devices.

  • Are there different models of the Ovatio CRT-D System, and how do they differ in terms of lead configurations and compatibility?

    Yes, the Ovatio CRT-D System includes multiple models: ZL101, ZL102, Intensia CRT-D, and Platinium CRT-D variants (1711, 1741). These models vary in lead configurations and are designed to be compatible with specific ELA Medical cardiac synchronization therapy pulse generators. The differences primarily lie in the lead design and pacing capabilities, ensuring tailored solutions for biventricular pacing in patients with heart failure.

  • What regulatory pathway was followed for the approval of the Ovatio CRT-D System, and what does this mean for clinicians and buyers?

    The Ovatio CRT-D System was approved through the FDA’s Premarket Approval (PMA) process, which is required for Class III devices. This rigorous pathway ensures the device meets stringent safety and effectiveness standards for treating life-threatening arrhythmias and improving heart failure symptoms. Clinicians and buyers can rely on this approval as evidence of the system’s compliance with FDA regulations, though they should always refer to the latest labeling and guidelines for specific clinical use.