PMA P040042S057

Device: Safire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S057
Product code: OAD
Decision date: 2025-04-10
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: an expansion of sterilization capabilities, including validation of the maximum load configuration, an addition of preconditioning room, and parametric release for Cycle 219 at Centerpiece in Tijuana, Mexico

Current openFDA PMA Record#

Device: Safire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy
Applicant: Irvine Biomedical,Inc.(Ibi)
PMA number: P040042
Supplement: S057
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-04-10
Decision code: OK30
Date received: 2025-03-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an expansion of sterilization capabilities, including validation of the maximum load configuration, an addition of preconditioning room, and parametric release for Cycle 219 at Centerpiece in Tijuana, Mexico