PMA P000022S001

Device

BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Applicant

Medtronic Vascular

PMA number

P000022

Supplement

S001

Product code

MAF

Decision date

2000-12-14

Generic name

STENT, CORONARY

Approval order statement

APPROVAL FOR A CHANGE IN THE LABELING TO THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE (RX) CORONARY STENT DELIVERY SYSTEM. THE DEVICE IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYNPTOMATIC ISCHENIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM. LONG TERM OUTCOME FOR THIS IMPLANT IS UNKNOWN AT PRESENT. THE RAPID EXCHANGE DELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY. THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND ALONE PTCA PERFUSION CATHETER.