PMA P960016S089

Device: Livewire TC Ablation Catheter
Applicant: St Jude Medical
PMA number: P960016
Supplement: S089
Product code: LPB
Decision date: 2022-12-08
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Alternate tier 3 supplier of resin for the FlexAbility/FlexAbility SE Ablation Catheters, TactiCath SE Ablation Catheter, Livewire TC Ablation Catheter, and Safire Ablation Catheter.

Current openFDA PMA Record#

Device: Livewire TC Ablation Catheter
Applicant: St Jude Medical
PMA number: P960016
Supplement: S089
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2022-12-08
Decision code: OK30
Date received: 2022-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate tier 3 supplier of resin for the FlexAbility/FlexAbility SE Ablation Catheters, TactiCath SE Ablation Catheter, Livewire TC Ablation Catheter, and Safire Ablation Catheter.