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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 NumberS016
Date Received11/16/2011
Decision Date12/20/2011
Product Code NWX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A SECOND STERILIZATION CYCLE, AND OF NEW EQUIPMENT FOR THE POUCH PEEL STRENGTH PROCESS.
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