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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namestent, coronary
Generic Namestent, coronary
two scimed place
maple grove, MN 
PMA NumberP980009
Date Received04/01/1998
Decision Date09/29/1998
Withdrawal Date 09/28/2007
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 99M-2028
Notice Date 06/24/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013