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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 NamePTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP020009
Supplement NumberS020
Date Received02/02/2005
Decision Date02/15/2005
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add a specification for acceptable pyrogen level to the hypotube component.
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