S660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM

FDA premarket approval P970035/S032 · decided 2002-01-31

Approval details

PMA number

P970035

Supplement

S032

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

S660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM

Generic name

STENT, CORONARY

Applicant

Medtronic, Ireland

Date received

2001-11-14

Decision date

2002-01-31

Days to decision

78 days

Decision code

APPR

Product code

MAF

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR THE MEDTRONIC AVE S660 2.75 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF ACUTE OR THREATENED CLOSURE DURING A PLANNED INTERVENTIONAL PROCEDURE IN DE NOVO LESIONS (<=24 MM IN LENGTH) IN NATIVE CORONARY ARTERY OR ARTERIAL BYPASS GRAFT CONDUIT WITH A REFERENCE DIAMETER BETWEEN 2.2 MM AND 2.9 MM. LONG-TERM OUTCOME (BEYOND 30 DAYS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT.

510(k) clearances by this applicant