FDA.reportPublic FDA data

PMA P130026S071

Device
TactiCath Contact Force Ablation Catheter, Sensor Enabled
Applicant
St Jude Medical
PMA number
P130026
Supplement
S071
Product code
OAE
Decision date
2021-05-18
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement
Changes to a resin as a result of transferring resin manufacturing from the current supplier manufacturing site in LaPorte, TX to a new supplier manufacturing site in Avon, OH.

Current openFDA PMA Record#

Device
TactiCath Contact Force Ablation Catheter, Sensor Enabled
Applicant
St Jude Medical
PMA number
P130026
Supplement
S071
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date
2021-05-18
Decision code
OK30
Date received
2021-04-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to a resin as a result of transferring resin manufacturing from the current supplier manufacturing site in LaPorte, TX to a new supplier manufacturing site in Avon, OH.