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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 NameEXPRESS MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC
PMA NumberP020009
Supplement NumberS067
Date Received10/21/2010
Decision Date11/19/2010
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to product family grouping for the purposes of microbiological sample designation at the maple grove manufacturing facilities for pre-sterile product monitoring activities.
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