PMA P040042S054

Device: Safire Ablation Catheter
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S054
Product code: OAD
Decision date: 2022-12-08
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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: Safire Ablation Catheter
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S054
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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.