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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMAGIC WALLSTENT SELF-EXPANDING CORONARY STENT
Classification Namestent, coronary
Generic Nameintravascular stent
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP980009
Supplement NumberS002
Date Received12/28/1998
Decision Date07/28/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? Yes
Combination Product No
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.
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