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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.
 
DeviceANGIOSCULPT PTCA SCORING BALLOON CATHETER
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantSPECTRANETICS CORP.
5055 BRANDIN COURT
FREMONT, CA 94538
PMA NumberP050018
Supplement NumberS007
Date Received05/20/2009
Decision Date06/19/2009
Product Code NWX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF FURTHER USER INSTRUCTIONS IN THE INSTRUCTIONS FOR USE (IFU) TO ENHANCE THE SAFE USE OF THE MONORAIL (EASY EXCHANGE) DELIVERY PLATFORM OF THE ANGIOSCULPT SCORING BALLOON CATHETER.
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