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Aveir VR Delivery Catheter LSCD111 +1 more model

FDA PMA

Class III (US FDA PMA)

PMA P150035

by Abbott Medical

Identity

Trade Name
Aveir VR Leadless System FDA PMA
Generic Name
Leadless pacemaker FDA PMA

Identifiers

PMA Number
P150035 FDA PMA
FDA Product Code
PNJ FDA PMA
Models / Variants
Aveir VR Delivery Catheter LSCD111 FDA PMA
Aveir DR Delivery Catheter LSCD201 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

The Aveir VR Delivery Catheter LSCD111 is a component of the Aveir VR Leadless System designed for the delivery and implantation of leadless pacemakers. It is used in cardiovascular procedures to place the pacemaker device directly into the heart chamber without leads.

This catheter is supplied as a sterile, single-use device intended for use in clinical settings by trained healthcare professionals. It is part of a system that has received FDA PMA approval (P150035) and is regulated under device class 3 for cardiovascular applications.

Frequently asked questions

What is the Aveir VR Delivery Catheter LSCD111 used for?

The Aveir VR Delivery Catheter LSCD111 is used to deliver and implant the Aveir VR leadless pacemaker into the heart chamber during a cardiovascular procedure. It enables leadless placement of the pacemaker device without the need for traditional leads.

Is the Aveir VR Delivery Catheter LSCD111 reusable or single-use?

The Aveir VR Delivery Catheter LSCD111 is supplied as a sterile, single-use device. It is intended for one-time use only and should not be reprocessed or reused after a procedure.

What regulatory authorization does the Aveir VR Delivery Catheter LSCD111 have?

The Aveir VR Delivery Catheter LSCD111 is part of a system that has received FDA PMA approval under application number P150035. This authorization is stated in the device data as FDA_PMA.

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 P150035 24 fields · synced Sep 18, 2026