PMA P020047S004

Device

MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM

Applicant

Abbott Vascular

PMA number

P020047

Supplement

S004

Product code

MAF

Decision date

2004-09-10

Classification

Stent, Coronary

Generic name

STENT, CORONARY

Approval order statement

APPROVAL FOR THE 2.75 MM LINE EXTENSION FOR THE MULTI-LINK VISION CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.75 MM.

Summary

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