PMA P020045S112

Device: 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S112
Product code: LPB
Decision date: 2025-03-27
Classification: Cardiovascular
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: the implementation of a minimum load sterilization configuration for the Freezor family of cardiac cryoablation catheters

Current openFDA PMA Record#

Device: 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S112
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
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