PMA P020025S111

Device

Blazer II XP Cardiac Ablation Catheter and Cable

Applicant

Boston Scientific

PMA number

P020025

Supplement

S111

Product code

OAD

Decision date

2018-09-07

Classification

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

Generic name

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

Approval order statement

Approval for updating the optimized BSC2000-2 cycle conducted in Chamber 7 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software.

Summary

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