S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM

FDA premarket approval P970035/S022 · decided 2001-04-04

Approval details

PMA number

P970035

Supplement

S022

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2000-10-20

Decision date

2001-04-04

Days to decision

166 days

Decision code

APPR

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR THE S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RZ) CORONARY STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM AND 4.0 MM. LONG TERM OUTCOME (BEYOND 14 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. THE RX RELIVERY SYSTEM WILL ALLOW FOR PERFUSION

510(k) clearances by this applicant