PMA P980001S017

Device

NIROYAL(TM1) ELITE PREMOUNTED STENT SYSTEM

Applicant

Boston Scientific Corp

PMA number

P980001

Supplement

S017

Decision date

2000-08-03

Approval order statement

APPROVAL FOR THE NIROYAL(TM) ELITE PROMOUNTED STENT SYSTEMS. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: *PATIENTS WITH SYMOPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 4.0 MM; * TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED IN TERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND * PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS WITH LESION LENGTH <= 30 MM AND REFERENCE DIAMETER IN THE RANGE OF 3.0 TO 4.0 MM.