FDA.reportPublic FDA data

PMA P130026S079

Device
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Applicant
St Jude Medical
PMA number
P130026
Supplement
S079
Product code
OAE
Decision date
2022-08-31
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement
New visual inspection to identify twists in the catheter fluid lumen in both the TactiCath SE Uni-Directional and Bi-Directional Handle Assembly manufacturing procedures.

Current openFDA PMA Record#

Device
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Applicant
St Jude Medical
PMA number
P130026
Supplement
S079
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date
2022-08-31
Decision code
OK30
Date received
2022-08-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New visual inspection to identify twists in the catheter fluid lumen in both the TactiCath SE Uni-Directional and Bi-Directional Handle Assembly manufacturing procedures.