Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. TWO SCIMED PLACE MAPLE GROVE, MN |
PMA Number | P980009 |
Supplement Number | S002 |
Date Received | 12/28/1998 |
Decision Date | 07/28/1999 |
Withdrawal Date
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09/28/2007 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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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