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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 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.
 
DeviceCROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES
Generic NameSTENT, CORONARY
ApplicantCORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-5700
PMA NumberP900043
Supplement NumberS015
Date Received03/30/1999
Decision Date09/14/1999
Withdrawal Date 09/02/2008
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to market a new stent system. The device is indicated for improving coronary luminal diameter in the following: Patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary arteries (length < 30 mm) with a reference vessel diameter of 3.0 to 4.0 mm. Long term outcome (beyond 6 months) for this permanent implant is unknown at present.
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