FDA.reportPublic FDA data

PMA P150026

Device
HeartLight Catheter, HeartLight X3 Console V2
Applicant
Cardiofocus, Inc.
PMA number
P150026
Supplement
S013
Product code
OAE
Decision date
2023-08-11
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement
Approval for the transition of the Console manufacturing from the current contractor, Minnetronix, 1635 Energy Park Dr, St Paul, MN 55108 USA to Gener8, 2560 Junction Ave., San Jose CA 95134 USA.

Current openFDA PMA Record#

Device
HeartLight Catheter, HeartLight X3 Console V2
Applicant
Cardiofocus, Inc.
PMA number
P150026
Supplement
S015
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date
2023-08-11
Decision code
APPR
Date received
2023-03-02
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the transition of the Console manufacturing from the current contractor, Minnetronix, 1635 Energy Park Dr, St Paul, MN 55108 USA to Gener8, 2560 Junction Ave., San Jose CA 95134 USA.