Express/Express 2 MR & Otw Coronary Stent Systems

FDA premarket approval P020009 · Stent, Coronary

PMA numberP020009

Approval

Applicant
Boston Scientific Scimed, Inc.
Received
March 15, 2002
Decision date
September 11, 2002 (APWD)
Supplements
120, latest August 10, 2016
Product code
MAF – Stent, Coronary

Official FDA PMA record

Approval order statement

APPROVAL FOR THE EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS. THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE ASSOCIATED WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH < 18 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 5.0 MM. 2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE (AC/TAC) IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS IN NATIVE CORONARY ARTERIES OF 2.25 TO 5.0 MM (INCLUSIVE) IN DIAMETER AND < 30 MM LONG. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.