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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, EASY EXCHANGE (EX0
Classification Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Generic Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Applicant
SPECTRANETICS CORP.
5055 brandin court
fremont, CA 94538
PMA NumberP050018
Supplement NumberS013
Date Received03/29/2011
Decision Date04/08/2011
Product Code
NWX[ Registered Establishments with NWX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF AN INFLATION LUMEN INSPECTION.
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