FDA.reportPublic FDA data

PMA P960016S087

Device
LiveWire TC Ablation Catheter and Safire Ablation Catheter
Applicant
St Jude Medical
Product code
LPB
Decision date
2021-05-18
Generic name
Cardiac ablation percutaneous catheter
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
LiveWire TC Ablation Catheter and Safire Ablation Catheter
Applicant
St Jude Medical
PMA number
P960016
Supplement
S087
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
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.