PMA P100010S126

Device: Arctic Front Advance, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter and Manual Retraction Kit
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S126
Product code: OAE
Decision date: 2022-03-15
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: Implementation of a parametric release method at the Sterigenics sterilization site (Sterigenics US LLC) in Queensbury, New York.

Current openFDA PMA Record#

Device: Arctic Front Advance, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter and Manual Retraction Kit
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S126
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2022-03-15
Decision code: OK30
Date received: 2022-02-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a parametric release method at the Sterigenics sterilization site (Sterigenics US LLC) in Queensbury, New York.