PMA P040042S048

Device: Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S048
Product code: OAD
Decision date: 2021-03-12
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: Approval for minor design changes to a printed circuit board assembly and a change in supplier for the manufacture of the printed circuit board assembly.

Current openFDA PMA Record#

Device: Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S048
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2021-03-12
Decision code: APPR
Date received: 2021-01-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for minor design changes to a printed circuit board assembly and a change in supplier for the manufacture of the printed circuit board assembly.