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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 NameROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK ADVANCER
Classification Namecatheter, coronary, atherectomy
ApplicantBOSTON SCIENTIFIC
PMA NumberP900056
Supplement NumberS102
Date Received07/27/2010
Decision Date08/26/2010
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate processing materials, and an alternate vendor used to manufacture a component of the rotablator series of devices.
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