PMA P020045S101

Device: Freezor TM Cardiac Cryoablation Catheter
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S101
Product code: LPB
Decision date: 2022-08-24
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Manufacturing and supplier changes to the female coaxial connector and female coaxial fitting of the Arctic Front Advance (AFA), Arctic Front Advance Pro (AFA Pro), Freezor, Freezor Xtra, and Freezor MAX cryoablation catheters.

Current openFDA PMA Record#

Device: Freezor TM Cardiac Cryoablation Catheter
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S101
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2022-08-24
Decision code: OK30
Date received: 2022-07-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing and supplier changes to the female coaxial connector and female coaxial fitting of the Arctic Front Advance (AFA), Arctic Front Advance Pro (AFA Pro), Freezor, Freezor Xtra, and Freezor MAX cryoablation catheters.