PMA P100010S119

Device: Arctic Front® Advance Cardiac Cryoablation Catheter
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S119
Product code: OAE
Decision date: 2021-11-05
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: Approval for a 2x sterilization process, adding a degassing chamber at an existing sterilization facility, and a reduction in biological indicators for routine sterilization.

Current openFDA PMA Record#

Device: Arctic Front® Advance Cardiac Cryoablation Catheter
Applicant: Medtronic Cryocath, LP
PMA number: P100010
Supplement: S119
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2021-11-05
Decision code: APPR
Date received: 2021-08-09
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a 2x sterilization process, adding a degassing chamber at an existing sterilization facility, and a reduction in biological indicators for routine sterilization.