PMA P020045S062

Device: FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S062
Product code: LPB
Decision date: 2014-10-01
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: ALTERNATE SUPPLIER TO MEDTRONIC CRYOCATH FOR THE ELECTRICAL CABLE SUBASSEMBLIES FOR THE ARCTIC FRONT ADVANCE/FREEZOR AND THE ELECTRICAL UMBILICAL CABLE.

Current openFDA PMA Record#

Device: FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S062
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2014-10-01
Decision code: OK30
Date received: 2014-09-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE SUPPLIER TO MEDTRONIC CRYOCATH FOR THE ELECTRICAL CABLE SUBASSEMBLIES FOR THE ARCTIC FRONT ADVANCE/FREEZOR AND THE ELECTRICAL UMBILICAL CABLE.