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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 PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER
Classification Namecatheter, coronary, atherectomy
ApplicantBOSTON SCIENTIFIC
PMA NumberP900056
Supplement NumberS101
Date Received11/10/2010
Decision Date01/07/2011
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a material and vendor change for the infusion hose of the rotablator rotalink plus and rotalink advancer and exchangeable catheter.
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