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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 NameCROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES
Classification Namestent, coronary
Generic Namecoronary stent and delivery system
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS015
Date Received03/30/1999
Decision Date09/14/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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