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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.
 
DeviceANGIOSCUPLT SCORING BALLOON CATHETER
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantSpectranetics Corp.
5055 Brandin Ct.
Fremont, CA 94538
PMA NumberP050018
Supplement NumberS001
Date Received02/07/2007
Decision Date03/07/2007
Product Code NWX 
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 MINOR CHANGES TO THE STRAIN RELIEF AND CATHETER SHAFT.
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