PMA P020045S093

Device
Freezor, Arctic Front Advance (AFA) CryoAblation Catheters
Applicant
Medtronic Cryocath, LP
PMA number
P020045
Supplement
S093
Product code
LPB
Decision date
2020-02-03
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
Use of Windows 10 operator system driver software.

Current openFDA PMA Record#

Device
Freezor, Arctic Front Advance (AFA) CryoAblation Catheters
Applicant
Medtronic Cryocath, LP
PMA number
P020045
Supplement
S093
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2020-02-03
Decision code
OK30
Date received
2020-01-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of Windows 10 operator system driver software.