PMA P040014

Device: Therapy Ablation Catheter (4mm Tip Thermistor and Bi-Directional); Cables
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S047
Product code: LPB
Decision date: 2025-04-10
Generic name: Cardiac ablation percutaneous catheter
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: Therapy Ablation Catheter (4mm Tip Thermistor and Bi-Directional); Cables
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S050
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
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