Magic Wallstent Endoprothesis

FDA premarket approval P980009 · Stent, Coronary

PMA numberP980009

Approval

Applicant
Boston Scientific Scimed, Inc.
Received
April 1, 1998
Decision date
September 29, 1998 (APWD)
Supplements
13, latest October 31, 2005
Product code
MAF – Stent, Coronary

Official FDA PMA record

Approval order statement

Approval for the Magic WALLSTENT(R) Endoprosthesis. This device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discreter de novo lesions in native coronary arteries (length <35mm) with a reference vessel diameter of 3.0 to 5.5mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 3.0 to 5.5mm.