PMA P900043

Device

BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN

Applicant

Cordis Corp.

PMA number

P900043

Supplement

S024

Product code

MAF

Decision date

2004-03-04

Generic name

STENT, CORONARY

Approval order statement

APPROVAL FOR A NEW SAPHENOUS VEIN GRAFT (SVG) INDICATION FOR THE BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS). THE DEVICE IS INDICATED FOR THE TREATMENT OF: PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<= 30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM;ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM; AND,PATIENTS WITH DE NOVO OR RESTENOTIC SAPHENOUS VEIN GRAFT LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM