Freezor Max Cardiac Cryoablation Catheter
PMA P100010
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP100010 | Date17 Dec 2010 | StatusActive |
Recalls
-
- Terminated Z-0149-2012
Medtronic CryoCath has identified specific lots of Arctic Front CryoAblation Catheters that were distributed with incorrect programming that may result in false expired catheter notifications. Impacted lots are 21571, 25375, 25376, 25377, and 25381 of the Arctic Front Catheter Model Number 2AF282. Medtronic CryoCath is communicating this information to the FDA. On affected catheters, the incor
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Arctic Front Cryocatheter System
- Generic Name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- PMA Number
- FDA Product Code
- OAE
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Freezor Max Cardiac Cryoablation Catheter is a percutaneous cardiac ablation device designed for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. It is part of the Arctic Front Cryocatheter System and is classified as a Class III device under FDA regulations.
This catheter is supplied sterile and intended for single-use in electrophysiology labs or cardiac catheterization suites. It is not MRI safe and must be stored according to manufacturer specifications. Authorization is granted via FDA PMA P100010.
Other devices from Medtronic Cryocath, LP
Questions
AI-generated answers, 18 Sep 2026
What is the Freezor Max Cardiac Cryoablation Catheter used for?
The device is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, as stated in the approval documentation for the Arctic Front Cryocatheter System.
Is the Freezor Max Cardiac Cryoablation Catheter reusable?
No, the device is supplied sterile and intended for single-use only, as is standard for percutaneous cardiac ablation catheters to prevent cross-contamination and ensure patient safety.
What regulatory authorization does the Freezor Max Cardiac Cryoablation Catheter have?
The device has received FDA Premarket Approval (PMA) under number P100010, which grants it legal authorization for marketing and use in the United States.