PMA P020025S107

Device

Blazer II XP/ Blazer Prime XP / Intella Tip MiFi XP / IntellaNav, IntellaNav MiFi XP

Applicant

Boston Scientific

PMA number

P020025

Supplement

S107

Product code

OAD

Decision date

2017-10-11

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 an automated wire pulling and stripping process.

Summary

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