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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, Rapid Exchange (RX)
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantSPECTRANETICS CORP.
5055 BRANDIN COURT
FREMONT, CA 94538
PMA NumberP050018
Supplement NumberS026
Date Received07/09/2019
Decision Date09/11/2020
Product Code NWX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for various design changes, including additional coating to the transition tube and modifications to the balloon, distal tip, and scoring element.
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