PMA P980009S002

Device: MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT
Applicant: Boston Scientific Scimed, Inc.
PMA number: P980009
Supplement: S002
Product code: MAF
Decision date: 1999-07-28
Generic name: STENT, CORONARY
Approval order statement: Approval to add an indication for the treatment of saphenous vein grafts. The device is now indicated for improving luminal diameter in the following: 1)pts w/symptomatic ischemic disease due to discrete de novo lesion in native coronary arteries (length < 35 mm) wiht a reference vessel diameter of 3.0 to 5.5 mm; 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 5.5 mm. 3) Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesions length < 35mm and reference vessel diameter in the range of 3.0 to 5.5mm.

Current openFDA PMA Record

Device: MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT
Applicant: Boston Scientific Scimed, Inc.
PMA number: P980009
Supplement: S002
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1999-07-28
Decision code: APPR
Date received: 1998-12-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to add an indication for the treatment of saphenous vein grafts. The device is now indicated for improving luminal diameter in the following: 1)pts w/symptomatic ischemic disease due to discrete de novo lesion in native coronary arteries (length < 35 mm) wiht a reference vessel diameter of 3.0 to 5.5 mm; 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 5.5 mm. 3) Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesions length < 35mm and reference vessel diameter in the range of 3.0 to 5.5mm.