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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 NameWALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980033
Supplement NumberS008
Date Received11/17/2003
Decision Date12/11/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of two manufacturing facilities located at boston scientific corp. , quincy, massachusetts and boston scientific european distribution center, maastricht-airport, the netherlands. These facilities will perform packaging and labeling operations for the wallstent endoprosthesis with the unistep plus delivery system.
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