PMA P100010S098

Device: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters
Applicant: Medtronic Cryocath, LP
Product code: OAE
Decision date: 2020-06-23
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: Approval for the Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months). The Freezor MAX Cardiac Cryoablation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal and persistent atrial fibrillation (episode duration less than 6 months) in conjunction with the Arctic Front Cryocatheter for the following uses:1) Gap cryoablation to complete electrical isolation of the pulmonary veins;2 Cryoablation of focal trigger sites; and3) Creation of ablation line between the inferior vena cava and the tricuspid valve.

Current openFDA PMA Record#

Device: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S098
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2020-06-23
Decision code: APPR
Date received: 2019-10-25
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months). The Freezor MAX Cardiac Cryoablation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal and persistent atrial fibrillation (episode duration less than 6 months) in conjunction with the Arctic Front Cryocatheter for the following uses:1) Gap cryoablation to complete electrical isolation of the pulmonary veins;2 Cryoablation of focal trigger sites; and3) Creation of ablation line between the inferior vena cava and the tricuspid valve.