PMA P130026S030

Device
TactiCath Quartz Ablation Catheter
Applicant
St Jude Medical
PMA number
P130026
Supplement
S030
Product code
OAE
Decision date
2018-03-07
Classification
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement
Implementation for the Cirrus Test System for the TactiCath Quartz Thermocouple Position Test.

Current openFDA PMA Record#

Device
TactiCath Quartz Ablation Catheter
Applicant
St Jude Medical
PMA number
P130026
Supplement
S030
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date
2018-03-07
Decision code
OK30
Date received
2018-02-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation for the Cirrus Test System for the TactiCath Quartz Thermocouple Position Test.