PMA P060019S035

Device

THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP AND THERAPY COOL PATH SP ABLATION CATHETERS, AND 1500T9-CP RF GENERATORS

Applicant

Irvine Biomedical, Inc.

PMA number

P060019

Supplement

S035

Product code

LPB

Decision date

2016-02-18

Classification

Cardiac Ablation Percutaneous Catheter

Generic name

Cardiac ablation percutaneous catheter

Approval order statement

Approval for 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.

Summary

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