PMA P110019S097

Device

XIENCE PRIME/SV/LL and XIENCE/SV/LL and XIENCE Alpine and XIENCE Sierra Everolimus Eluting Coronary Stent System

Applicant

Abbott Vascular

PMA number

P110019

Supplement

S097

Product code

NIQ

Decision date

2018-02-21

Classification

Coronary Drug-eluting Stent

Generic name

Coronary drug-eluting stent

Approval order statement

Change the time point when pyrogen testing for ethylene oxide (EO) sterilized products is conducted for products manufactured at its facility located in Clonmel, Ireland.

Summary

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