PMA P020025S108

Device

Blazer II XP Cardiac RF Ablation System(also branded as as Blazer (II XP, PRime XP); IntellaTip MiFi XP; IntellaNav XP a

Applicant

Boston Scientific

PMA number

P020025

Supplement

S108

Product code

OAD

Decision date

2017-11-01

Classification

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

Generic name

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

Approval order statement

Update the software control system and the vacuum pump used in Sterilization Chamber 1 at the BSC Coventry Rhode Island facility.

Summary

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