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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.
 
DeviceNIR PREMOUNTED STENT DELIVERY SYSTEMS
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Corp.
One Boston Scientific Place
Natick, MA 01760
PMA NumberP980001
Supplement NumberS043
Date Received06/27/2003
Decision Date07/25/2003
Withdrawal Date 08/13/2007
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE MANUFACTURING COATING PROCESS FOR ALL CURRENTLY MARKETED PTCA CATHETERS AND CORONARY STENT (BALLOON EXPANDABLE) DELIVERY SYSTEMS.
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