Skip to content

7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System

by Medtronic Cryocath, LP

PMA P020045

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

2 closed

Documents

PMA P020045↗

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 NumberP020045 Date17 Apr 2003ApprovedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2777-2015 FDA Class II initiated 1 Sep 2015

    An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

    • Terminated Z-1452-06 FDA Unclassified (pre-2012) initiated 4 Aug 2006

    Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Cardiac ablation percutaneous catheter
PMA Number
FDA Product Code
LPB
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 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System is a cardiac ablation percutaneous catheter system indicated for the cryoablation of the conducting tissues of the heart. It is used in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT).

Supplied by Medtronic Cryocath, LP, the system received FDA PMA approval (P020045) on April 17, 2003. It is a Class III device under product code LPB, intended for percutaneous cardiac ablation procedures under physician supervision.

Other devices from Medtronic Cryocath, LP

See all devices from Medtronic Cryocath, LP →

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 is the 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System indicated for?

    The system is indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT), as stated in the approval documentation.

  • Who manufactures the 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System?

    The system is manufactured by Medtronic Cryocath, LP, located in Mounds View, Minnesota, as specified in the device data.

  • What regulatory pathway was used for the 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System?

    The device received approval through the FDA Premarket Approval (PMA) pathway, with PMA number P020045 and decision date of April 17, 2003.