MICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM

FDA premarket approval P030009/S020 · decided 2008-10-22

Approval details

PMA number

P030009

Supplement

S020

Supplement type

Normal 180 Day Track

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

MICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2008-03-31

Decision date

2008-10-22

Days to decision

205 days

Decision code

APPR

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR THE ADDITION OF THE MICRO-DRIVER RAPID EXCHANGE DELIVERY PLATFORMAND THE ADDITION OF THE MEDTRONIC MEXICO FACILITY IN TIJUANA FOR THE MANUFACTURING OF CATHETERSUB-ASSEMBLIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MICRO-DRIVERRAPID EXCHANGE (RX) CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS WITH REFERENCE VESSEL DIAMETERS OF 2.25 - 2.75 MM AND

510(k) clearances by this applicant