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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 NamePALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY OVER THE WIRE DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent and delivery system
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS016
Date Received05/19/1999
Decision Date05/27/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a label to the outside front panel of the minicrown carton that states the following: "do not induce a vacuum on the delivery system prior to reaching the target lesion. ".
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