Driver Over-The-Wire, Rapid Exchange, and Multi-Exchange Coronary Stent Systems

FDA premarket approval P030009 · Stent, Coronary

PMA numberP030009

Approval

Applicant
Medtronic, Ireland
Received
April 10, 2003
Decision date
October 1, 2003 (APWD)
Supplements
100, latest July 15, 2022
Product code
MAF – Stent, Coronary

Official FDA PMA record

Approval order statement

APPROVAL FOR THE DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS. THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS WITH REFERENCE VESSEL DIAMETERS OF 3.0 - 4.0 MM AND <= 30 MM IN LENGTH USING DIRECT STENTING OR PRE-DILATATION. OUTCOME BEYOND 270 DAYS FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.