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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 NameCROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent and delivery system
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS022
Date Received01/31/2000
Decision Date03/02/2000
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of the manufacturing process to form balloon shoulders at the distal and proximal ends of the stent.
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