FDA.reportPublic FDA data

PMA P130026S068

Device
TactiCath Quartz Catheter and TactiSys Quartz Equipment
Applicant
St Jude Medical
PMA number
P130026
Supplement
S068
Product code
OAE
Decision date
2021-03-12
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement
Approval for minor design changes to a printed circuit board assembly and a change in supplier for the manufacture of the printed circuit board assembly.

Current openFDA PMA Record#

Device
TactiCath Quartz Catheter and TactiSys Quartz Equipment
Applicant
St Jude Medical
PMA number
P130026
Supplement
S068
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date
2021-03-12
Decision code
APPR
Date received
2021-01-13
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor design changes to a printed circuit board assembly and a change in supplier for the manufacture of the printed circuit board assembly.