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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.
 
DeviceTAXUS EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP030025
Supplement NumberS002
Date Received04/05/2004
Decision Date05/05/2004
Withdrawal Date12/06/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO IMPLEMENT THE FOLLOWING: 1) THE ADDITION OF AN ADDITIONAL IN-PROCESS INSPECTION, 2) MODIFICATION OF A CURRENT IN-PROCESS INSPECTION, AND 3) MODIFICATION OF A MANUFACTURING PROCESS TO ADDRESS COMPLAINTS RELATED TO FAILURE OF THE DELIVERY SYSTEM BALLOON TO PROPERLY DEFLATE FOLLOWING STENT DEPLOYMENT.
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