TactiFlex Ablation Catheter, Sensor Enabled

FDA PMA

Class III (US FDA PMA)

PMA P220013

by Abbott Medical

Identity

Trade Name: TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C FDA PMA
Generic Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation FDA PMA

Identifiers

PMA Number: P220013 FDA PMA
FDA Product Code: OAE FDA PMA

Classification

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

The TactiFlex Ablation Catheter, Sensor Enabled is a percutaneous cardiac ablation device designed for cardiac electrophysiological mapping. It is indicated for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter.

This device is intended for use in conjunction with a compatible radiofrequency generator and a three-dimensional mapping system. It has received FDA PMA authorization for clinical application in the treatment of specific cardiac arrhythmias.

Frequently asked questions

What is the primary use of the TactiFlex Ablation Catheter?

The catheter is used for cardiac electrophysiological mapping and the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter.

Does the TactiFlex catheter require additional equipment to function?

Yes, the device must be used in conjunction with a compatible radiofrequency generator and a three-dimensional mapping system to perform its intended functions.

Has the TactiFlex Ablation Catheter received regulatory approval?

Yes, the device has received FDA PMA (Premarket Approval) authorization for its indicated use in cardiac electrophysiological procedures.

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	P220013	Class III	Active

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Manufacturer

Manufacturer: Abbott Medical

Sources (1)

FDA PMA P220013 24 fields · synced Sep 18, 2026