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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Generic Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
5055 brandin court
fremont, CA 94538
PMA NumberP050018
Date Received05/11/2005
Decision Date01/08/2007
Product Code
NWX[ Registered Establishments with NWX ]
Docket Number 07M-0032
Notice Date 01/23/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S021 S022