DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS

FDA premarket approval P030009 · decided 2003-10-01

Approval details

PMA number

P030009

Trade name

DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2003-04-10

Decision date

2003-10-01

Days to decision

174 days

Decision code

APWD

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

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.

510(k) clearances by this applicant