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Afp Cardiac Pacing System, Sensolog Cardiac Pacing System, And Synchrony Cardia…

FDA PMA

Class III (US FDA PMA)

PMA P880086

by Abbott Medical

Identity

Trade Name
ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS FDA PMA
Generic Name
implantable pacemaker Pulse-generator FDA PMA

Identifiers

PMA Number
P880086 FDA PMA
FDA Product Code
DXY FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 870.3610 FDA PMA
Regulation Number
870.3610 FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

This device is an implantable pacemaker pulse-generator, classified as a Class III medical device under FDA regulations. It is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm, thereby preventing bradycardia or other arrhythmias.

The system is intended for surgical implantation and is supplied sterile for single-use. Each model is approved under FDA_PMA (PMA Number: P880086) and adheres to regulatory standards for cardiovascular devices. Models include various pacemaker types, each with distinct programming capabilities and lead configurations, and are intended for use in clinical settings by trained healthcare professionals.

Frequently asked questions

What types of pacemakers are included in this system, and how do they differ in programming capabilities?

This system includes multiple pacemaker models under the trade names ACCENT, IDENTITY, VERITY, VICTORY, and ZEPHYR. Each model is designed with distinct programming capabilities and lead configurations tailored for specific clinical needs, such as single-chamber, dual-chamber, or biventricular pacing. The differences lie in their ability to synchronize contractions, adjust pacing rates, and deliver tailored electrical impulses based on the patient’s heart rhythm requirements.

Are these pacemakers intended for reuse, or are they single-use devices?

These pacemakers are supplied sterile and intended for single-use only after surgical implantation. They are not designed for reuse, as their sterile packaging ensures safety and compliance with medical device regulations for cardiovascular implants.

How should these devices be stored before use, and what are the implications for shelf life?

The devices are supplied sterile and should be stored according to the manufacturer’s instructions, typically in a clean, dry environment protected from extreme temperatures and moisture. While the exact shelf life isn’t specified, the sterile packaging and regulatory compliance (FDA_PMA) ensure they meet rigorous standards for longevity and reliability when stored properly.

What regulatory pathway was followed for approval, and how does this affect clinical use?

These pacemakers were approved via the FDA Premarket Approval (PMA) pathway, a rigorous process for Class III devices. This means they underwent extensive clinical testing to demonstrate safety and effectiveness before being authorized for use in clinical settings by trained healthcare professionals. The approval ensures compliance with FDA standards for cardiovascular devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA PMA P880086 24 fields · synced Sep 18, 2026