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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceANGIOSCULPT SCORING BALLOON CATHETER
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantSPECTRANETICS CORP.
5055 BRANDIN COURT
FREMONT, CA 94538
PMA NumberP050018
Date Received05/11/2005
Decision Date01/08/2007
Product Code NWX 
Docket Number 07M-0032
Notice Date 01/23/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ANGIOSCULPT SCORING BALLOON CATHETER. THE DEVICE IS INDICATED FOR THE TREATMENT OF HEMODYNAMICALLY SIGNIFICANT CORONARY ARTERY STENOSIS, INCLUDING IN-STENT RESTENOSIS AND COMPLEX TYPE C LESIONS, FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S021 S022 S024 S025 S026 
S027 S028 S030 S031 S032 S033 S034 
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