PMA P100010S151

Device: ARCTIC FRONT CRYOCATHETER SYSTEM
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S151
Product code: OAE
Decision date: 2025-03-18
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: the addition of an alternate supplier for injection-molded components used in the Arctic Front Advance and Arctic Front Advance Pro handles

Current openFDA PMA Record#

Device: ARCTIC FRONT CRYOCATHETER SYSTEM
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S151
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-03-18
Decision code: OK30
Date received: 2025-03-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of an alternate supplier for injection-molded components used in the Arctic Front Advance and Arctic Front Advance Pro handles