PMA P100010S150

Device: ARCTIC FRONT CRYOCATHETER SYSTEM
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S150
Product code: OAE
Decision date: 2025-03-27
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: the implementation of a minimum load sterilization configuration for the Freezor family of cardiac cryoablation catheters

Current openFDA PMA Record#

Device: ARCTIC FRONT CRYOCATHETER SYSTEM
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S150
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-03-27
Decision code: OK30
Date received: 2025-02-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the implementation of a minimum load sterilization configuration for the Freezor family of cardiac cryoablation catheters