PMA P020045S100

Device: Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S100
Product code: LPB
Decision date: 2022-03-15
Generic name: Cardiac ablation percutaneous catheter
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: Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S100
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
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.