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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
Two Scimed Pl.
Maple Grove, MN 55311
PMA NumberP900056
Supplement NumberS101
Date Received08/17/2010
Decision Date01/07/2011
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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