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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 ATHERECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
ApplicantMAQUET CARDIOVASCULAR LLC
PMA NumberP900056
Supplement NumberS115
Date Received05/25/2012
Decision Date06/20/2012
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 
Removal of two inspection steps from rotalink burr assembly process.
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