Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Medtronic Cryocath, LP; 8200 Coral Sea St.; Mounds View, MN 55112
• PMA Number: P020045
• Supplement Number: S073
• Date Received: 01/28/2016
• Decision Date: 08/31/2016
• Product Code: LPB
• Docket Number: 16M-2649
• Notice Date: 09/09/2016
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT01426425
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Freezor Xtra Cardiac CryoAblation Catheter, CryoConsole system, and related accessories. The device is indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT). The Freezor Xtra catheter is also intended for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Freezor Xtra catheter freezes the target tissue and blocks the electrical conduction by creating an inflammatory response or cryonecrosis.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling