PMA P040042S042

Device

Electrophysiology Cable; SE-Safire TX, Catheter Extension Cable; Therapy 8mm, Thermistor, Dual 8, Safire TX Ablation Cat

Applicant

Irvine Biomedical,Inc.(Ibi)

PMA number

P040042

Supplement

S042

Product code

OAD

Decision date

2019-04-11

Classification

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Generic name

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Approval order statement

Implementation of a new biological indicator as a monitoring control.

Summary

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