PMA P040014S030

Device: THERAPY ABLATION CATHETER (INCLUDING BI-DIRECTIONAL) THERAPY 4MM THERMISTOR ABLATION CATHETER
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S030
Product code: LPB
Decision date: 2016-06-24
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Acceptance to replace test equipment (RF generators) used for final inspection testing for the Therapy Ablation Series Catheters.

Current openFDA PMA Record#

Device: THERAPY ABLATION CATHETER (INCLUDING BI-DIRECTIONAL) THERAPY 4MM THERMISTOR ABLATION CATHETER
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S030
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2016-06-24
Decision code: OK30
Date received: 2016-05-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Acceptance to replace test equipment (RF generators) used for final inspection testing for the Therapy Ablation Series Catheters.