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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 NameROTATIONAL ATHERECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
ApplicantBOSTON SCIENTIFIC
PMA NumberP900056
Supplement NumberS104
Date Received04/01/2011
Decision Date08/31/2011
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the rotawire and rotalink burr/ rotalink plus instructions for use (ifu).
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