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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, coronary
Generic Nameintravascular stent
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013