FDA.reportPublic FDA data

PMA P020045S092

Device
Freezor Cardiac Cryoablation Catheter
Applicant
Medtronic Cryocath, LP
Product code
LPB
Decision date
2020-03-02
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
Approval for an alternate manufacturing site (Medtronic Mexico, Tijuana Baja California, Mexico), as well as a new sterilization site (Midwestern Sterilization, Jackson, Missouri)and packaging improvements for Coaxial umbilical component of the CryoAblation System.

Current openFDA PMA Record#

Device
Freezor Cardiac Cryoablation Catheter
Applicant
Medtronic Cryocath, LP
PMA number
P020045
Supplement
S092
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2020-03-02
Decision code
APPR
Date received
2019-12-19
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an alternate manufacturing site (Medtronic Mexico, Tijuana Baja California, Mexico), as well as a new sterilization site (Midwestern Sterilization, Jackson, Missouri)and packaging improvements for Coaxial umbilical component of the CryoAblation System.