PMA P020025S003

Device

EPT-1000 XP RF ABLATION SYSTEMS

Applicant

Boston Scientific

PMA number

P020025

Supplement

S003

Product code

OAD

Decision date

2004-01-07

Classification

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

Generic name

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

Approval order statement

CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.

Summary

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