PMA P040014S028

Device: THERAPY ABLATION CATHETERS
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S028
Product code: LPB
Decision date: 2016-02-18
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Approval of software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.

Current openFDA PMA Record#

Device: THERAPY ABLATION CATHETERS
Applicant: Irvine Biomedical, Inc.
PMA number: P040014
Supplement: S028
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2016-02-18
Decision code: APPR
Date received: 2015-11-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval of software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.