PMA P970020S023

Device

MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM

Applicant

Abbott Vascular, Inc.

PMA number

P970020

Supplement

S023

Product code

MAF

Decision date

2000-10-03

Generic name

STENT, CORONARY

Approval order statement

APPROVAL FOR THE ACS MULTI-LINK RX AND OTW TETRA(TM) CORONARY STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM; AND 2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 MM TO 4.0 MM. LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. NOTE: THE 2.5 MM AND 2.75 MM DIAMETER STENTS AND THE 33 MM AND 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE.