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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 NumberS006
Date Received05/18/2009
Decision Date10/30/2009
Product Code NWX 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODIFICATION TO THE CURRENT BACTERIAL ENDOTOXIN (LAL) TESTING PLAN.
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