Durata/Riata ST Optim/Riata ST Family of Leads

FDA PMA

Class III (US FDA PMA)

PMA P950022

by Abbott Medical

Identity

Trade Name: TVL(TM) LEAD SYSTEM FDA PMA
Generic Name: Implantable cardioverter defibrillator (non-CRT) FDA PMA

Identifiers

PMA Number: P950022 FDA PMA
FDA Product Code: LWS FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA

The device is an implantable cardioverter defibrillator (non-CRT) lead system. It is designed for use in transvenous right ventricular, superior vena cava, and subcutaneous applications as part of the TVL Lead System.

Supplied as implantable leads and associated accessories including lead tunnelers, Y-adapters, and external stimulator adapters. The system received FDA PMA approval (P950022) on May 10, 1996, and is intended for use in cardiovascular procedures under physician supervision.

Frequently asked questions

What is the generic name of the device according to the FDA?

The generic name of the device is Implantable cardioverter defibrillator (non-CRT), as specified in the openfda field under device_name.

Which manufacturer is responsible for this device?

Abbott Medical is the manufacturer, as listed in both the MANUFACTURER and applicant fields of the device data.

What regulatory authorization does this device have?

The device has FDA PMA authorization, indicated by the AUTHORIZATIONS field showing FDA_PMA and the PMA number P950022 with a decision date of 1996-05-10.

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

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P950022	Class III	Active

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Manufacturer

Manufacturer: Abbott Medical

Sources (1)

FDA PMA P950022 24 fields · synced Sep 18, 2026